Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study

Objective To evaluate non‐invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments. Methods One hundred fifty subjects were...

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Published in:	Headache Vol. 56; no. 8; pp. 1317 - 1332
Main Authors:	Silberstein, Stephen D., Mechtler, Laszlo L., Kudrow, David B., Calhoun, Anne H., McClure, Candace, Saper, Joel R., Liebler, Eric J., Rubenstein Engel, Emily, Tepper, Stewart J.
Format:	Journal Article
Language:	English
Published:	United States Blackwell Publishing Ltd 01.09.2016 Wiley Subscription Services, Inc John Wiley and Sons Inc
Subjects:	acute treatment chronic cluster headache Cluster Headache - therapy Double-Blind Method episodic cluster headache Female Headaches Humans Male Middle Aged neuromodulation non-invasive vagus nerve stimulation Pain Measurement Population randomized controlled trial Research Submission Research Submissions Response rates Treatment Outcome United States Vagus Nerve Stimulation - instrumentation Vagus Nerve Stimulation - methods neuromodulation chronic cluster headache non-invasive vagus nerve stimulation episodic cluster headache acute treatment randomized controlled trial
ISSN:	0017-8748, 1526-4610
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Abstract	Objective To evaluate non‐invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments. Methods One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double‐blind phase; completers could enter a 3‐month nVNS open‐label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15‐60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified. Results The intent‐to‐treat population comprised 133 subjects: 60 nVNS‐treated (eCH, n = 38; cCH, n = 22) and 73 sham‐treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS‐treated subjects and 15.1% of sham‐treated subjects (P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P = .008) and total population (P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double‐blind phase and 18/128 subjects in the open‐label phase. No serious ADEs occurred. Conclusions In one of the largest randomized sham‐controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well‐tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817.
AbstractList	Objective To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments. Methods One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified. Results The intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n=38; cCH, n=22) and 73 sham-treated (eCH, n=47; cCH, n=26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects (P=.1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P=.008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P=.008) and total population (P=.04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred. Conclusions In one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817. Objective To evaluate non‐invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments. Methods One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double‐blind phase; completers could enter a 3‐month nVNS open‐label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15‐60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified. Results The intent‐to‐treat population comprised 133 subjects: 60 nVNS‐treated (eCH, n = 38; cCH, n = 22) and 73 sham‐treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS‐treated subjects and 15.1% of sham‐treated subjects (P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P = .008) and total population (P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double‐blind phase and 18/128 subjects in the open‐label phase. No serious ADEs occurred. Conclusions In one of the largest randomized sham‐controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well‐tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817. To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments. One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified. The intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n = 38; cCH, n = 22) and 73 sham-treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects (P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P = .008) and total population (P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred. In one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817. OBJECTIVETo evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.BACKGROUNDMany patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.METHODSOne hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified.RESULTSThe intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n = 38; cCH, n = 22) and 73 sham-treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects (P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P = .008) and total population (P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred.CONCLUSIONSIn one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817.
Author	Liebler, Eric J. Rubenstein Engel, Emily Mechtler, Laszlo L. Calhoun, Anne H. Saper, Joel R. Silberstein, Stephen D. McClure, Candace Kudrow, David B. Tepper, Stewart J.
AuthorAffiliation	10 Dr. Tepper was at Cleveland Clinic Headache Center Cleveland, OH, at the time of study completion 1 Department of Neurology Jefferson Headache Center Philadelphia PA USA 6 Michigan Head Pain and Neurological Institute Ann Arbor MI USA 9 Department of Neurology Geisel School of Medicine at Dartmouth Hanover NH USA 5 North American Science Associates Inc Minneapolis MN USA 4 Carolina Headache Institute Durham NC USA 3 California Medical Clinic for Headache Santa Monica CA USA 7 Department of Scientific, Medical and Governmental Affairs, electroCore LLC Basking Ridge NJ USA 2 Department of Neurology and Neuro-Oncology Dent Neurologic Headache Center Amherst NY USA 8 Dalessio Headache Center at Scripps Clinic La Jolla CA USA
AuthorAffiliation_xml	– name: 8 Dalessio Headache Center at Scripps Clinic La Jolla CA USA – name: 7 Department of Scientific, Medical and Governmental Affairs, electroCore LLC Basking Ridge NJ USA – name: 6 Michigan Head Pain and Neurological Institute Ann Arbor MI USA – name: 5 North American Science Associates Inc Minneapolis MN USA – name: 9 Department of Neurology Geisel School of Medicine at Dartmouth Hanover NH USA – name: 3 California Medical Clinic for Headache Santa Monica CA USA – name: 1 Department of Neurology Jefferson Headache Center Philadelphia PA USA – name: 2 Department of Neurology and Neuro-Oncology Dent Neurologic Headache Center Amherst NY USA – name: 4 Carolina Headache Institute Durham NC USA – name: 10 Dr. Tepper was at Cleveland Clinic Headache Center Cleveland, OH, at the time of study completion
Author_xml	– sequence: 1 givenname: Stephen D. surname: Silberstein fullname: Silberstein, Stephen D. email: stephen.silberstein@jefferson.edu, stephen.silberstein@jefferson.edu organization: Department of Neurology, Jefferson Headache Center, PA, Philadelphia, USA – sequence: 2 givenname: Laszlo L. surname: Mechtler fullname: Mechtler, Laszlo L. organization: Department of Neurology and Neuro-Oncology, Dent Neurologic Headache Center, NY, Amherst, USA – sequence: 3 givenname: David B. surname: Kudrow fullname: Kudrow, David B. organization: California Medical Clinic for Headache, CA, Santa Monica, USA – sequence: 4 givenname: Anne H. surname: Calhoun fullname: Calhoun, Anne H. organization: Carolina Headache Institute, NC, Durham, USA – sequence: 5 givenname: Candace surname: McClure fullname: McClure, Candace organization: North American Science Associates Inc, MN, Minneapolis, USA – sequence: 6 givenname: Joel R. surname: Saper fullname: Saper, Joel R. organization: Michigan Head Pain and Neurological Institute, MI, Ann Arbor, USA – sequence: 7 givenname: Eric J. surname: Liebler fullname: Liebler, Eric J. organization: Department of Scientific, Medical and Governmental Affairs, electroCore, LLC, NJ, Basking Ridge, USA – sequence: 8 givenname: Emily surname: Rubenstein Engel fullname: Rubenstein Engel, Emily organization: Dalessio Headache Center at Scripps Clinic, CA, La Jolla, USA – sequence: 9 givenname: Stewart J. surname: Tepper fullname: Tepper, Stewart J. organization: Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/27593728$$D View this record in MEDLINE/PubMed
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Cites_doi	10.1111/head.12145 10.1177/0333102415570497 10.2165/00003495-200262010-00003 10.1037/0022-006X.67.3.332 10.1177/0333102410391489 10.1046/j.1468-2982.1995.1506452.x 10.1177/0333102413485658 10.1177/0333102412473667 10.3109/10601331003777444 10.1016/j.brs.2012.09.013 10.1212/WNL.0000000000001394 10.1212/WNL.54.9.1832 10.1016/S0091-3022(03)00028-1 10.2165/00023210-200418060-00001 10.1212/WNL.0b013e3181eb58c8 10.1177/0333102415607070 10.1111/j.1468-2982.2007.01330.x 10.1016/0304-3959(79)90049-6 10.1186/s10194-015-0545-1 10.1001/jama.2009.1855 10.1111/j.1526-4610.2010.01830.x 10.1016/S1474-4422(02)00104-7 10.1016/S0022-3476(99)70241-6 10.3109/15622975.2010.541281 10.1016/0304-3959(79)90050-2 10.1056/NEJM199108013250505 10.1177/0333102410372423 10.1002/ana.10786 10.1111/j.1468-1331.2006.01566.x 10.1111/j.1468-2982.2008.01592.x 10.1007/PL00007854 10.1016/j.jpain.2009.07.007 10.1016/j.nicl.2014.10.003
ContentType	Journal Article
Copyright	2016 The Authors Headache published by Wiley Periodicals, Inc. on behalf of American Headache Society 2016 The Authors Headache published by Wiley Periodicals, Inc. on behalf of American Headache Society. 2016 American Headache Society
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Keywords	neuromodulation chronic cluster headache non-invasive vagus nerve stimulation episodic cluster headache acute treatment randomized controlled trial
Language	English
License	Attribution-NonCommercial http://creativecommons.org/licenses/by-nc/4.0 2016 The Authors Headache published by Wiley Periodicals, Inc. on behalf of American Headache Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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Notes	ark:/67375/WNG-G9ZVKB0B-4 istex:E50511417A0C197AB48651E9D8766CA033EC0202 electroCore, LLC ArticleID:HEAD12896 Financial Support Stephen D. Silberstein, MD, has received consultancy and advisory board fees from Alder Biopharmaceuticals Inc., Allergan, Inc., Amgen, Inc., Avanir Pharmaceuticals, Inc., Depomed, Inc., Dr. Reddy's Laboratories Ltd., electroCore, LLC, eNeura Inc., Ipsen Biopharmaceuticals Inc., Medscape, LLC, Medtronic, Inc., Mitsubishi Tanabe Pharma America, Inc., National Institute of Neurological Disorders and Stroke, St. Jude Medical, Inc., Supernus Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., and Trigemina, Inc.; Laszlo L. Mechtler, MD, has received speaker fees from Allergan, Inc., Depomed, Inc., and Supernus Pharmaceuticals, Inc., and research support from Celldex Therapeutics, Cincinnati Children's Hospital Medical Center, GlaxoSmithKline, PharmaNet Group Ltd., and Questcor Pharmaceuticals, Inc.; David B. Kudrow, MD, has received speaker fees from Teva Pharmaceutical Industries Ltd. and grant funding from Depomed, Inc.; Anne H. Calhoun, MD, has received advisory board fees from Allergan, Inc., Depomed, Inc., Eli Lilly and Company, and Teva Pharmaceutical Industries Ltd., and speaker fees from Depomed, Inc., Merck & Co., Inc., and Teva Pharmaceutical Industries Ltd. Dr. Calhoun has also received research support from Autonomic Technologies, Inc., electroCore, LLC, and Scion NeuroStim, LLC; Candace McClure, PhD, is an employee of NAMSA; Joel R. Saper, MD, has received consultancy fees from Alder Biopharmaceuticals Inc., Allergan, Inc., Johnson & Johnson (Ethicon, Inc.), Migraine Research Foundation, NuPathe Inc., Purdue Pharma L.P., Supernus Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., and Tian Pharmaceutical Co. Ltd. Dr. Saper has also received research grants from Achelios Therapeutics, Inc., Alder Biopharmaceuticals Inc., Allergan, Inc., Amgen, Inc., Astellas Pharma Inc., Autonomic Technologies, Inc., Cerephex Corporation, Daiichi‐Sankyo Co. Ltd., Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, GlaxoSmithKline, Labrys Biologics, Inc., Merck & Co., Inc., Pfizer, Inc., Scion NeuroStim, LLC, Vanda Pharmaceuticals, and Winston Laboratories, Inc.; Eric J. Liebler is an employee of electroCore, LLC, and receives stock ownership; Emily Rubenstein Engel, MD, has received consultancy, speaker, and advisory board fees from Allergan, Inc., Depomed, Inc., and electroCore, LLC; and Stewart J. Tepper, MD, has received consultancy fees from Acorda Therapeutics, Inc., Allergan, Inc., Amgen, Inc., Autonomic Technologies, Inc. (ATI), Avanir Pharmaceuticals, Inc., Depomed, Inc., Dr. Reddy's Laboratories Ltd., electroCore, LLC, Impax Pharmaceuticals, Inc., Pfizer, Inc., Scion NeuroStim, LLC, Teva Pharmaceutical Industries Ltd., Theorem Clinical Research, Zogenix, Inc., and Zosano Pharma Corporation. Dr. Tepper has also received research grants/support from Allergan, Inc., Amgen, Inc., Autonomic Technologies, Inc. (ATI), Avanir Pharmaceuticals, Inc., electroCore, LLC, eNeura Inc., GlaxoSmithKline, Merck & Co., Inc., Pfizer, Inc., Optinose US Inc./Avanir Pharmaceuticals, Inc./Otsuka Pharmaceutical Co., Ltd., Teva Pharmaceutical Industries Ltd., and Zogenix, Inc. He has also received stock options from Autonomic Technologies, Inc. (ATI) and royalties from the University Press of Mississippi and Springer. This study was sponsored by electroCore, LLC. Professional writing and editorial support from MedLogix Communications, LLC, funded by electroCore, LLC, were under the direction of authors throughout draft development and revisions in accordance with International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Data analysis support from NAMSA was funded by electroCore, LLC. The authors are guarantors of this document, which expresses the opinions and conclusions of the authors and not those of their corresponding affiliations. Conflict of Interest ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3 Financial Support: This study was sponsored by electroCore, LLC. Professional writing and editorial support from MedLogix Communications, LLC, funded by electroCore, LLC, were under the direction of authors throughout draft development and revisions in accordance with International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Data analysis support from NAMSA was funded by electroCore, LLC. The authors are guarantors of this document, which expresses the opinions and conclusions of the authors and not those of their corresponding affiliations. Conflict of Interest: Stephen D. Silberstein, MD, has received consultancy and advisory board fees from Alder Biopharmaceuticals Inc., Allergan, Inc., Amgen, Inc., Avanir Pharmaceuticals, Inc., Depomed, Inc., Dr. Reddy's Laboratories Ltd., electroCore, LLC, eNeura Inc., Ipsen Biopharmaceuticals Inc., Medscape, LLC, Medtronic, Inc., Mitsubishi Tanabe Pharma America, Inc., National Institute of Neurological Disorders and Stroke, St. Jude Medical, Inc., Supernus Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., and Trigemina, Inc.; Laszlo L. Mechtler, MD, has received speaker fees from Allergan, Inc., Depomed, Inc., and Supernus Pharmaceuticals, Inc., and research support from Celldex Therapeutics, Cincinnati Children's Hospital Medical Center, GlaxoSmithKline, PharmaNet Group Ltd., and Questcor Pharmaceuticals, Inc.; David B. Kudrow, MD, has received speaker fees from Teva Pharmaceutical Industries Ltd. and grant funding from Depomed, Inc.; Anne H. Calhoun, MD, has received advisory board fees from Allergan, Inc., Depomed, Inc., Eli Lilly and Company, and Teva Pharmaceutical Industries Ltd., and speaker fees from Depomed, Inc., Merck & Co., Inc., and Teva Pharmaceutical Industries Ltd. Dr. Calhoun has also received research support from Autonomic Technologies, Inc., electroCore, LLC, and Scion NeuroStim, LLC; Candace McClure, PhD, is an employee of NAMSA; Joel R. Saper, MD, has received consultancy fees from Alder Biopharmaceuticals Inc., Allergan, Inc., Johnson & Johnson (Ethicon, Inc.), Migraine Research Foundation, NuPathe Inc., Purdue Pharma L.P., Supernus Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., and Tian Pharmaceutical Co. Ltd. Dr. Saper has also received research grants from Achelios Therapeutics, Inc., Alder Biopharmaceuticals Inc., Allergan, Inc., Amgen, Inc., Astellas Pharma Inc., Autonomic Technologies, Inc., Cerephex Corporation, Daiichi‐Sankyo Co. Ltd., Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, GlaxoSmithKline, Labrys Biologics, Inc., Merck & Co., Inc., Pfizer, Inc., Scion NeuroStim, LLC, Vanda Pharmaceuticals, and Winston Laboratories, Inc.; Eric J. Liebler is an employee of electroCore, LLC, and receives stock ownership; Emily Rubenstein Engel, MD, has received consultancy, speaker, and advisory board fees from Allergan, Inc., Depomed, Inc., and electroCore, LLC; and Stewart J. Tepper, MD, has received consultancy fees from Acorda Therapeutics, Inc., Allergan, Inc., Amgen, Inc., Autonomic Technologies, Inc. (ATI), Avanir Pharmaceuticals, Inc., Depomed, Inc., Dr. Reddy's Laboratories Ltd., electroCore, LLC, Impax Pharmaceuticals, Inc., Pfizer, Inc., Scion NeuroStim, LLC, Teva Pharmaceutical Industries Ltd., Theorem Clinical Research, Zogenix, Inc., and Zosano Pharma Corporation. Dr. Tepper has also received research grants/support from Allergan, Inc., Amgen, Inc., Autonomic Technologies, Inc. (ATI), Avanir Pharmaceuticals, Inc., electroCore, LLC, eNeura Inc., GlaxoSmithKline, Merck & Co., Inc., Pfizer, Inc., Optinose US Inc./Avanir Pharmaceuticals, Inc./Otsuka Pharmaceutical Co., Ltd., Teva Pharmaceutical Industries Ltd., and Zogenix, Inc. He has also received stock options from Autonomic Technologies, Inc. (ATI) and royalties from the University Press of Mississippi and Springer.
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References	Schuh-Hofer S, Reuter U, Kinze S, Einhäupl KM, Arnold G. Treatment of acute cluster headache with 20 mg sumatriptan nasal spray-an open pilot study. J Neurol. 2002;249:94-99. Francis GJ, Becker WJ, Pringsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology. 2010;75:463-473. Law S, Derry S, Moore RA. Triptans for acute cluster headache. Cochrane Database Syst Rev. 2013;7:CD008042. Martelletti P, Mitsikostas DD. Cluster headache: A quasi-rare disorder needing a reappraisal. J Headache Pain. 2015;16:59. Yuan H, Silberstein SD. Vagus nerve stimulation and headache. Headache. 2015 Oct 16. doi: 10.1111/head.12721. [Epub ahead of print]. The Sumatriptan Cluster Headache Study Group. Treatment of acute cluster headache with sumatriptan. N Engl J Med. 1991;325:322-326. Schoenen J, Jensen RH, Lantéri-Minet M, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study. Cephalalgia. 2013;33:816-830. May A, Leone M, Afra J, et al. EFNS Task Force. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias. Eur J Neurol. 2006;13:1066-1077. Landy S, Rice K, Lobo B. Central sensitisation and cutaneous allodynia in migraine: Implications for treatment. CNS Drugs. 2004;18:337-342. Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24:9-160. Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: A randomized trial. JAMA. 2009;302:2451-2457. Naegel S, Holle D, Desmarattes N, et al. Cortical plasticity in episodic and chronic cluster headache. Neuroimage Clin. 2014;6:415-423. Ferguson AV, Samson WK. The orexin/hypocretin system: A critical regulator of neuroendocrine and autonomic function. Front Neuroendocrinol. 2003;24:141-150. Burstein R, Collins B, Jakubowski M. Defeating migraine pain with triptans: A race against the development of cutaneous allodynia. Ann Neurol. 2004;55:19-26. Jürgens TP, Gaul C, Lindwurm A, et al. Impairment in episodic and chronic cluster headache. Cephalalgia. 2011;31:671-682. Becker WJ. Cluster headache: Conventional pharmacological management. Headache. 2013;53:1191-1196. Goadsby PJ. Pathophysiology of cluster headache: A trigeminal autonomic cephalgia. Lancet Neurol. 2002;1:251-257. Aaronson ST, Carpenter LL, Conway CR, et al. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: Acute and chronic effects. Brain Stimul. 2013;6:631-640. Braunstein D, Donnet A, Pradel V, et al. Triptans use and overuse: A pharmacoepidemiology study from the French health insurance system database covering 4.1 million people. Cephalalgia. 2015;35:1172-1180. Nesbitt AD, Marin JCA, Tompkins E, Ruttledge MH, Goadsby PJ. Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment. Neurology. 2015;84:1249-1253. Headache Classification Committee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33:629-808. Rakel B, Cooper N, Adams HJ, et al. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain. 2010;11:230-238. Marmura MJ, Pello SJ, Young WB. Interictal pain in cluster headache. Cephalalgia. 2010;30:1531-1534. Murphy JV. Left vagal nerve stimulation in children with medically refractory epilepsy. The Pediatric VNS Study Group. J Pediatr. 1999;134:563-566. Broadbent HJ, van den Eynde F, Guillaume S, et al. Blinding success of rTMS applied to the dorsolateral prefrontal cortex in randomised sham-controlled trials: A systematic review. World J Biol Psychiatry. 2011;12:240-248. Kazdin AE. The meanings and measurement of clinical significance. J Consult Clin Psychol. 1999;67:332-339. Bahra A, Gawel MJ, Hardebo JE, Millson D, Breen SA, Goadsby PJ. Oral zolmitriptan is effective in the acute treatment of cluster headache. Neurology. 2000;54:1832-1839. IMITREX [Package Insert]. Research Triangle Park, NC: GlaxoSmithKline; 2015. Dihydroergotamine Mesylate [Package Insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2002. Ashkenazi A, Schwedt T. Cluster headache-acute and prophylactic therapy. Headache. 2011;51:272-286. Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clin Res Regul Aff. 2010;27:42-51. Silberstein SD, Calhoun AH, Lipton RB, et al. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Headache. 2016 Jul 13. pii: 10.1212/WNL.0000000000002918. [Epub ahead of print]. Ekbom K, Hardebo JE. Cluster headache: Aetiology, diagnosis and management. Drugs. 2002;62:61-69. Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). I. Effects on dorsal horn convergent neurones in the rat. Pain. 1979;6:283-304. Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on non-convergent neurones, supraspinal involvement and theoretical implications. Pain. 1979;6:305-327. Fischera M, Marziniak M, Gralow I, Evers S. The incidence and prevalence of cluster headache: A meta-analysis of population-based studies. Cephalalgia. 2008;28:614-618. Jensen RM, Lyngberg A, Jensen RH. Burden of cluster headache. Cephalalgia. 2007;27:535-541. Gaul C, Diener HC, Silver N, et al. Non-invasive vagus nerve stimulation for prevention and acute treatment of chronic cluster headache (PREVA): A randomised controlled study. Cephalalgia. 2016;36:534-546. Lipton RB, Micieli G, Russell D, Solomon S, Tfelt-Hansen P, Waldenlind E. Guidelines for controlled trials of drugs in cluster headache. Cephalalgia. 1995;15:452-462. 2015; 35 2010; 11 2010; 75 2015; 16 2006; 13 1995; 15 2004; 24 2002; 1 2011; 31 1999; 67 2011; 12 2002 2013; 7 2013; 6 2016; 36 2004; 55 2010; 27 2013; 33 2004; 18 2015; 84 2002; 62 2000; 54 2013; 53 2011; 51 2008; 28 2003; 24 1979; 6 2002; 249 2015 1999; 134 1991; 325 2014; 6 2010; 30 2009; 302 2007; 27 Yuan H (e_1_2_11_16_1) e_1_2_11_10_1 e_1_2_11_32_1 e_1_2_11_30_1 e_1_2_11_36_1 e_1_2_11_14_1 e_1_2_11_13_1 e_1_2_11_35_1 e_1_2_11_34_1 e_1_2_11_33_1 e_1_2_11_7_1 e_1_2_11_29_1 e_1_2_11_6_1 e_1_2_11_28_1 e_1_2_11_27_1 e_1_2_11_4_1 e_1_2_11_26_1 e_1_2_11_3_1 e_1_2_11_2_1 Silberstein SD (e_1_2_11_39_1) Headache Classification Subcommittee of the International Headache Society. (e_1_2_11_5_1) 2004; 24 e_1_2_11_21_1 e_1_2_11_20_1 (e_1_2_11_12_1) 2015 e_1_2_11_25_1 e_1_2_11_40_1 e_1_2_11_24_1 e_1_2_11_9_1 e_1_2_11_23_1 e_1_2_11_8_1 e_1_2_11_22_1 e_1_2_11_18_1 e_1_2_11_17_1 e_1_2_11_15_1 (e_1_2_11_11_1) 2002 e_1_2_11_37_1 e_1_2_11_38_1 e_1_2_11_19_1 Law S (e_1_2_11_31_1) 2013; 7 23122916 - Brain Stimul. 2013 Jul;6(4):631-40 10228290 - J Pediatr. 1999 May;134(5):563-6 23314784 - Cephalalgia. 2013 Jul;33(10):816-30 17459083 - Cephalalgia. 2007 Jun;27(6):535-41 14979299 - Cephalalgia. 2004;24 Suppl 1:9-160 20974600 - Cephalalgia. 2010 Dec;30(12):1531-4 460935 - Pain. 1979 Jun;6(3):283-304 10369053 - J Consult Clin Psychol. 1999 Jun;67(3):332-9 27593725 - Headache. 2016 Sep;56(8):1251-2 12849458 - Lancet Neurol. 2002 Aug;1(4):251-7 26113477 - J Headache Pain. 2015;16:59 19945354 - J Pain. 2010 Mar;11(3):230-8 14596809 - Front Neuroendocrinol. 2003 Jul;24(3):141-50 23773141 - Headache. 2013 Jul-Aug;53(7):1191-6 15089101 - CNS Drugs. 2004;18(6):337-42 25667299 - Cephalalgia. 2015 Nov;35(13):1172-80 23771276 - Cephalalgia. 2013 Jul;33(9):629-808 27412146 - Neurology. 2016 Aug 2;87(5):529-38 26473407 - Headache. 2017 Apr;57 Suppl 1:29-33 26391457 - Cephalalgia. 2016 May;36(6):534-46 24353996 - Cochrane Database Syst Rev. 2013 Jul 17;(7):CD008042 14705108 - Ann Neurol. 2004 Jan;55(1):19-26 460936 - Pain. 1979 Jun;6(3):305-27 20679639 - Neurology. 2010 Aug 3;75(5):463-73 25713002 - Neurology. 2015 Mar 24;84(12):1249-53 8706107 - Cephalalgia. 1995 Dec;15(6):452-62 21123629 - Cephalalgia. 2011 Apr;31(6):671-82 16987158 - Eur J Neurol. 2006 Oct;13(10):1066-77 21284609 - Headache. 2011 Feb;51(2):272-86 25379455 - Neuroimage Clin. 2014 Oct 18;6:415-23 21426265 - World J Biol Psychiatry. 2011 Jun;12(4):240-8 1647496 - N Engl J Med. 1991 Aug 1;325(5):322-6 19996400 - JAMA. 2009 Dec 9;302(22):2451-7 11954875 - J Neurol. 2002 Jan;249(1):94-9 10802793 - Neurology. 2000 May 9;54(9):1832-9 11790156 - Drugs. 2002;62(1):61-9 18422717 - Cephalalgia. 2008 Jun;28(6):614-8
References_xml	– reference: Ferguson AV, Samson WK. The orexin/hypocretin system: A critical regulator of neuroendocrine and autonomic function. Front Neuroendocrinol. 2003;24:141-150. – reference: Burstein R, Collins B, Jakubowski M. Defeating migraine pain with triptans: A race against the development of cutaneous allodynia. Ann Neurol. 2004;55:19-26. – reference: Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: A randomized trial. JAMA. 2009;302:2451-2457. – reference: Aaronson ST, Carpenter LL, Conway CR, et al. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: Acute and chronic effects. Brain Stimul. 2013;6:631-640. – reference: Silberstein SD, Calhoun AH, Lipton RB, et al. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Headache. 2016 Jul 13. pii: 10.1212/WNL.0000000000002918. [Epub ahead of print]. – reference: Marmura MJ, Pello SJ, Young WB. Interictal pain in cluster headache. Cephalalgia. 2010;30:1531-1534. – reference: The Sumatriptan Cluster Headache Study Group. Treatment of acute cluster headache with sumatriptan. N Engl J Med. 1991;325:322-326. – reference: Schuh-Hofer S, Reuter U, Kinze S, Einhäupl KM, Arnold G. Treatment of acute cluster headache with 20 mg sumatriptan nasal spray-an open pilot study. J Neurol. 2002;249:94-99. – reference: Kazdin AE. The meanings and measurement of clinical significance. J Consult Clin Psychol. 1999;67:332-339. – reference: Schoenen J, Jensen RH, Lantéri-Minet M, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study. Cephalalgia. 2013;33:816-830. – reference: Murphy JV. Left vagal nerve stimulation in children with medically refractory epilepsy. The Pediatric VNS Study Group. J Pediatr. 1999;134:563-566. – reference: Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24:9-160. – reference: Rakel B, Cooper N, Adams HJ, et al. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain. 2010;11:230-238. – reference: Headache Classification Committee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33:629-808. – reference: Goadsby PJ. Pathophysiology of cluster headache: A trigeminal autonomic cephalgia. Lancet Neurol. 2002;1:251-257. – reference: Becker WJ. Cluster headache: Conventional pharmacological management. Headache. 2013;53:1191-1196. – reference: Broadbent HJ, van den Eynde F, Guillaume S, et al. Blinding success of rTMS applied to the dorsolateral prefrontal cortex in randomised sham-controlled trials: A systematic review. World J Biol Psychiatry. 2011;12:240-248. – reference: Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). I. Effects on dorsal horn convergent neurones in the rat. Pain. 1979;6:283-304. – reference: Gaul C, Diener HC, Silver N, et al. Non-invasive vagus nerve stimulation for prevention and acute treatment of chronic cluster headache (PREVA): A randomised controlled study. Cephalalgia. 2016;36:534-546. – reference: Martelletti P, Mitsikostas DD. Cluster headache: A quasi-rare disorder needing a reappraisal. J Headache Pain. 2015;16:59. – reference: Ashkenazi A, Schwedt T. Cluster headache-acute and prophylactic therapy. Headache. 2011;51:272-286. – reference: Landy S, Rice K, Lobo B. Central sensitisation and cutaneous allodynia in migraine: Implications for treatment. CNS Drugs. 2004;18:337-342. – reference: Lipton RB, Micieli G, Russell D, Solomon S, Tfelt-Hansen P, Waldenlind E. Guidelines for controlled trials of drugs in cluster headache. Cephalalgia. 1995;15:452-462. – reference: Law S, Derry S, Moore RA. Triptans for acute cluster headache. Cochrane Database Syst Rev. 2013;7:CD008042. – reference: Francis GJ, Becker WJ, Pringsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology. 2010;75:463-473. – reference: Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on non-convergent neurones, supraspinal involvement and theoretical implications. Pain. 1979;6:305-327. – reference: Naegel S, Holle D, Desmarattes N, et al. Cortical plasticity in episodic and chronic cluster headache. Neuroimage Clin. 2014;6:415-423. – reference: Ekbom K, Hardebo JE. Cluster headache: Aetiology, diagnosis and management. Drugs. 2002;62:61-69. – reference: IMITREX [Package Insert]. Research Triangle Park, NC: GlaxoSmithKline; 2015. – reference: Jürgens TP, Gaul C, Lindwurm A, et al. Impairment in episodic and chronic cluster headache. Cephalalgia. 2011;31:671-682. – reference: Fischera M, Marziniak M, Gralow I, Evers S. The incidence and prevalence of cluster headache: A meta-analysis of population-based studies. Cephalalgia. 2008;28:614-618. – reference: Jensen RM, Lyngberg A, Jensen RH. Burden of cluster headache. Cephalalgia. 2007;27:535-541. – reference: Nesbitt AD, Marin JCA, Tompkins E, Ruttledge MH, Goadsby PJ. Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment. Neurology. 2015;84:1249-1253. – reference: Yuan H, Silberstein SD. Vagus nerve stimulation and headache. Headache. 2015 Oct 16. doi: 10.1111/head.12721. [Epub ahead of print]. – reference: Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clin Res Regul Aff. 2010;27:42-51. – reference: May A, Leone M, Afra J, et al. EFNS Task Force. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias. Eur J Neurol. 2006;13:1066-1077. – reference: Bahra A, Gawel MJ, Hardebo JE, Millson D, Breen SA, Goadsby PJ. Oral zolmitriptan is effective in the acute treatment of cluster headache. Neurology. 2000;54:1832-1839. – reference: Dihydroergotamine Mesylate [Package Insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2002. – reference: Braunstein D, Donnet A, Pradel V, et al. Triptans use and overuse: A pharmacoepidemiology study from the French health insurance system database covering 4.1 million people. Cephalalgia. 2015;35:1172-1180. – volume: 33 start-page: 629 year: 2013 end-page: 808 article-title: The International Classification of Headache Disorders, 3rd edition (beta version) publication-title: Cephalalgia. – volume: 11 start-page: 230 year: 2010 end-page: 238 article-title: A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment publication-title: J Pain. – volume: 62 start-page: 61 year: 2002 end-page: 69 article-title: Cluster headache: Aetiology, diagnosis and management publication-title: Drugs. – volume: 24 start-page: 9 year: 2004 end-page: 160 article-title: The International Classification of Headache Disorders publication-title: Cephalalgia. – volume: 53 start-page: 1191 year: 2013 end-page: 1196 article-title: Cluster headache: Conventional pharmacological management publication-title: Headache. – volume: 249 start-page: 94 year: 2002 end-page: 99 article-title: Treatment of acute cluster headache with 20 mg sumatriptan nasal spray–an open pilot study publication-title: J Neurol. – volume: 31 start-page: 671 year: 2011 end-page: 682 article-title: Impairment in episodic and chronic cluster headache publication-title: Cephalalgia. – volume: 7 start-page: CD008042 year: 2013 article-title: Triptans for acute cluster headache publication-title: Cochrane Database Syst Rev. – volume: 30 start-page: 1531 year: 2010 end-page: 1534 article-title: Interictal pain in cluster headache publication-title: Cephalalgia. – volume: 24 start-page: 141 year: 2003 end-page: 150 article-title: The orexin/hypocretin system: A critical regulator of neuroendocrine and autonomic function publication-title: Front Neuroendocrinol. – volume: 6 start-page: 631 year: 2013 end-page: 640 article-title: Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment‐resistant depression: Acute and chronic effects publication-title: Brain Stimul. – volume: 6 start-page: 283 year: 1979 end-page: 304 article-title: Diffuse noxious inhibitory controls (DNIC). I. Effects on dorsal horn convergent neurones in the rat publication-title: Pain. – volume: 33 start-page: 816 year: 2013 end-page: 830 article-title: Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH‐1: A randomized, sham‐controlled study publication-title: Cephalalgia. – volume: 6 start-page: 415 year: 2014 end-page: 423 article-title: Cortical plasticity in episodic and chronic cluster headache publication-title: Neuroimage Clin. – volume: 55 start-page: 19 year: 2004 end-page: 26 article-title: Defeating migraine pain with triptans: A race against the development of cutaneous allodynia publication-title: Ann Neurol. – volume: 13 start-page: 1066 year: 2006 end-page: 1077 article-title: EFNS Task Force. EFNS guidelines on the treatment of cluster headache and other trigeminal‐autonomic cephalalgias publication-title: Eur J Neurol. – volume: 6 start-page: 305 year: 1979 end-page: 327 article-title: Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on non‐convergent neurones, supraspinal involvement and theoretical implications publication-title: Pain. – article-title: Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study publication-title: Headache. – volume: 67 start-page: 332 year: 1999 end-page: 339 article-title: The meanings and measurement of clinical significance publication-title: J Consult Clin Psychol. – volume: 325 start-page: 322 year: 1991 end-page: 326 article-title: The Sumatriptan Cluster Headache Study Group. Treatment of acute cluster headache with sumatriptan publication-title: N Engl J Med. – volume: 134 start-page: 563 year: 1999 end-page: 566 article-title: Left vagal nerve stimulation in children with medically refractory epilepsy. The Pediatric VNS Study Group publication-title: J Pediatr. – volume: 36 start-page: 534 year: 2016 end-page: 546 article-title: Non‐invasive vagus nerve stimulation for prevention and acute treatment of chronic cluster headache (PREVA): A randomised controlled study publication-title: Cephalalgia. – volume: 16 start-page: 59 year: 2015 article-title: Cluster headache: A quasi‐rare disorder needing a reappraisal publication-title: J Headache Pain. – volume: 18 start-page: 337 year: 2004 end-page: 342 article-title: Central sensitisation and cutaneous allodynia in migraine: Implications for treatment publication-title: CNS Drugs. – volume: 28 start-page: 614 year: 2008 end-page: 618 article-title: The incidence and prevalence of cluster headache: A meta‐analysis of population‐based studies publication-title: Cephalalgia. – volume: 15 start-page: 452 year: 1995 end-page: 462 article-title: Guidelines for controlled trials of drugs in cluster headache publication-title: Cephalalgia. – volume: 302 start-page: 2451 year: 2009 end-page: 2457 article-title: High‐flow oxygen for treatment of cluster headache: A randomized trial publication-title: JAMA. – volume: 51 start-page: 272 year: 2011 end-page: 286 article-title: Cluster headache–acute and prophylactic therapy publication-title: Headache. – year: 2002 – volume: 27 start-page: 535 year: 2007 end-page: 541 article-title: Burden of cluster headache publication-title: Cephalalgia. – volume: 12 start-page: 240 year: 2011 end-page: 248 article-title: Blinding success of rTMS applied to the dorsolateral prefrontal cortex in randomised sham‐controlled trials: A systematic review publication-title: World J Biol Psychiatry. – volume: 54 start-page: 1832 year: 2000 end-page: 1839 article-title: Oral zolmitriptan is effective in the acute treatment of cluster headache publication-title: Neurology. – volume: 84 start-page: 1249 year: 2015 end-page: 1253 article-title: Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment publication-title: Neurology. – volume: 75 start-page: 463 year: 2010 end-page: 473 article-title: Acute and preventive pharmacologic treatment of cluster headache publication-title: Neurology. – volume: 35 start-page: 1172 year: 2015 end-page: 1180 article-title: Triptans use and overuse: A pharmacoepidemiology study from the French health insurance system database covering 4.1 million people publication-title: Cephalalgia. – volume: 27 start-page: 42 year: 2010 end-page: 51 article-title: Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol publication-title: Clin Res Regul Aff. – year: 2015 – volume: 1 start-page: 251 year: 2002 end-page: 257 article-title: Pathophysiology of cluster headache: A trigeminal autonomic cephalgia publication-title: Lancet Neurol. – article-title: Vagus nerve stimulation and headache publication-title: Headache. – ident: e_1_2_11_10_1 doi: 10.1111/head.12145 – ident: e_1_2_11_15_1 doi: 10.1177/0333102415570497 – ident: e_1_2_11_14_1 doi: 10.2165/00003495-200262010-00003 – ident: e_1_2_11_23_1 doi: 10.1037/0022-006X.67.3.332 – ident: e_1_2_11_7_1 doi: 10.1177/0333102410391489 – ident: e_1_2_11_21_1 doi: 10.1046/j.1468-2982.1995.1506452.x – ident: e_1_2_11_2_1 doi: 10.1177/0333102413485658 – ident: e_1_2_11_40_1 doi: 10.1177/0333102412473667 – ident: e_1_2_11_22_1 doi: 10.3109/10601331003777444 – ident: e_1_2_11_37_1 doi: 10.1016/j.brs.2012.09.013 – ident: e_1_2_11_19_1 doi: 10.1212/WNL.0000000000001394 – ident: e_1_2_11_33_1 doi: 10.1212/WNL.54.9.1832 – ident: e_1_2_11_17_1 doi: 10.1016/S0091-3022(03)00028-1 – ident: e_1_2_11_36_1 doi: 10.2165/00023210-200418060-00001 – ident: e_1_2_11_8_1 doi: 10.1212/WNL.0b013e3181eb58c8 – ident: e_1_2_11_20_1 doi: 10.1177/0333102415607070 – ident: e_1_2_11_6_1 doi: 10.1111/j.1468-2982.2007.01330.x – ident: e_1_2_11_27_1 doi: 10.1016/0304-3959(79)90049-6 – volume: 7 start-page: CD008042 year: 2013 ident: e_1_2_11_31_1 article-title: Triptans for acute cluster headache publication-title: Cochrane Database Syst Rev. – ident: e_1_2_11_18_1 doi: 10.1186/s10194-015-0545-1 – ident: e_1_2_11_29_1 doi: 10.1001/jama.2009.1855 – ident: e_1_2_11_13_1 doi: 10.1111/j.1526-4610.2010.01830.x – ident: e_1_2_11_3_1 doi: 10.1016/S1474-4422(02)00104-7 – volume-title: IMITREX [Package Insert] year: 2015 ident: e_1_2_11_12_1 – ident: e_1_2_11_39_1 article-title: Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study publication-title: Headache. – ident: e_1_2_11_38_1 doi: 10.1016/S0022-3476(99)70241-6 – ident: e_1_2_11_24_1 doi: 10.3109/15622975.2010.541281 – ident: e_1_2_11_26_1 doi: 10.1016/0304-3959(79)90050-2 – volume: 24 start-page: 9 year: 2004 ident: e_1_2_11_5_1 article-title: The International Classification of Headache Disorders publication-title: Cephalalgia. – ident: e_1_2_11_28_1 doi: 10.1056/NEJM199108013250505 – ident: e_1_2_11_34_1 doi: 10.1177/0333102410372423 – ident: e_1_2_11_35_1 doi: 10.1002/ana.10786 – ident: e_1_2_11_9_1 doi: 10.1111/j.1468-1331.2006.01566.x – ident: e_1_2_11_4_1 doi: 10.1111/j.1468-2982.2008.01592.x – ident: e_1_2_11_30_1 doi: 10.1007/PL00007854 – ident: e_1_2_11_16_1 article-title: Vagus nerve stimulation and headache publication-title: Headache. – ident: e_1_2_11_25_1 doi: 10.1016/j.jpain.2009.07.007 – ident: e_1_2_11_32_1 doi: 10.1016/j.nicl.2014.10.003 – volume-title: Dihydroergotamine Mesylate [Package Insert] year: 2002 ident: e_1_2_11_11_1 – reference: 16987158 - Eur J Neurol. 2006 Oct;13(10):1066-77 – reference: 18422717 - Cephalalgia. 2008 Jun;28(6):614-8 – reference: 1647496 - N Engl J Med. 1991 Aug 1;325(5):322-6 – reference: 20974600 - Cephalalgia. 2010 Dec;30(12):1531-4 – reference: 11790156 - Drugs. 2002;62(1):61-9 – reference: 27593725 - Headache. 2016 Sep;56(8):1251-2 – reference: 17459083 - Cephalalgia. 2007 Jun;27(6):535-41 – reference: 23314784 - Cephalalgia. 2013 Jul;33(10):816-30 – reference: 21284609 - Headache. 2011 Feb;51(2):272-86 – reference: 10369053 - J Consult Clin Psychol. 1999 Jun;67(3):332-9 – reference: 25667299 - Cephalalgia. 2015 Nov;35(13):1172-80 – reference: 10228290 - J Pediatr. 1999 May;134(5):563-6 – reference: 27412146 - Neurology. 2016 Aug 2;87(5):529-38 – reference: 23771276 - Cephalalgia. 2013 Jul;33(9):629-808 – reference: 21123629 - Cephalalgia. 2011 Apr;31(6):671-82 – reference: 25379455 - Neuroimage Clin. 2014 Oct 18;6:415-23 – reference: 19996400 - JAMA. 2009 Dec 9;302(22):2451-7 – reference: 14596809 - Front Neuroendocrinol. 2003 Jul;24(3):141-50 – reference: 15089101 - CNS Drugs. 2004;18(6):337-42 – reference: 14705108 - Ann Neurol. 2004 Jan;55(1):19-26 – reference: 23122916 - Brain Stimul. 2013 Jul;6(4):631-40 – reference: 25713002 - Neurology. 2015 Mar 24;84(12):1249-53 – reference: 20679639 - Neurology. 2010 Aug 3;75(5):463-73 – reference: 460936 - Pain. 1979 Jun;6(3):305-27 – reference: 24353996 - Cochrane Database Syst Rev. 2013 Jul 17;(7):CD008042 – reference: 19945354 - J Pain. 2010 Mar;11(3):230-8 – reference: 26473407 - Headache. 2017 Apr;57 Suppl 1:29-33 – reference: 460935 - Pain. 1979 Jun;6(3):283-304 – reference: 12849458 - Lancet Neurol. 2002 Aug;1(4):251-7 – reference: 21426265 - World J Biol Psychiatry. 2011 Jun;12(4):240-8 – reference: 11954875 - J Neurol. 2002 Jan;249(1):94-9 – reference: 14979299 - Cephalalgia. 2004;24 Suppl 1:9-160 – reference: 8706107 - Cephalalgia. 1995 Dec;15(6):452-62 – reference: 23773141 - Headache. 2013 Jul-Aug;53(7):1191-6 – reference: 26113477 - J Headache Pain. 2015;16:59 – reference: 10802793 - Neurology. 2000 May 9;54(9):1832-9 – reference: 26391457 - Cephalalgia. 2016 May;36(6):534-46
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Snippet	Objective To evaluate non‐invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience... To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Many patients with CH experience excruciating attacks at a... Objective To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience... OBJECTIVETo evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.BACKGROUNDMany patients with CH experience...
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SubjectTerms	acute treatment chronic cluster headache Cluster Headache - therapy Double-Blind Method episodic cluster headache Female Headaches Humans Male Middle Aged neuromodulation non-invasive vagus nerve stimulation Pain Measurement Population randomized controlled trial Research Submission Research Submissions Response rates Treatment Outcome United States Vagus Nerve Stimulation - instrumentation Vagus Nerve Stimulation - methods
Title	Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study
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