Therapies to Restore Consciousness in Patients with Severe Brain Injuries: A Gap Analysis and Future Directions

Background/Objective For patients with disorders of consciousness (DoC) and their families, the search for new therapies has been a source of hope and frustration. Almost all clinical trials in patients with DoC have been limited by small sample sizes, lack of placebo groups, and use of heterogeneou...

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Vydané v:Neurocritical care Ročník 35; číslo Suppl 1; s. 68 - 85
Hlavní autori: Edlow, Brian L., Sanz, Leandro R. D., Polizzotto, Len, Pouratian, Nader, Rolston, John D., Snider, Samuel B., Thibaut, Aurore, Stevens, Robert D., Gosseries, Olivia
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: New York Springer US 01.07.2021
Springer Nature B.V
Humana Press
Predmet:
Brain Injuries, Traumatic - therapy
Clinical trials
Coma
Coma - etiology
Coma - therapy
Consciousness
Consciousness Disorders - etiology
Consciousness Disorders - therapy
Critical Care Medicine
Curing Coma Campaign
Deep brain stimulation
disorders of consciousness
gap analysis
Human health sciences
Humans
Hypothalamus
Intensive
Internal Medicine
Medicine
Medicine & Public Health
Neural networks
Neurogenesis
Neuroimaging
Neurologie
Neurology
Neurosurgery
Patients
precision medicine
Sciences de la santé humaine
Self expression
Stem cells
The Curing Coma Campaign
Transcranial magnetic stimulation
Coma
Gap analysis
Consciousness
Precision medicine
Disorders of consciousness
ISSN:1541-6933, 1556-0961, 1556-0961
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Shrnutí:Background/Objective For patients with disorders of consciousness (DoC) and their families, the search for new therapies has been a source of hope and frustration. Almost all clinical trials in patients with DoC have been limited by small sample sizes, lack of placebo groups, and use of heterogeneous outcome measures. As a result, few therapies have strong evidence to support their use; amantadine is the only therapy recommended by current clinical guidelines, specifically for patients with DoC caused by severe traumatic brain injury. To foster and advance development of consciousness-promoting therapies for patients with DoC, the Curing Coma Campaign convened a Coma Science Work Group to perform a gap analysis. Methods We consider five classes of therapies: (1) pharmacologic; (2) electromagnetic; (3) mechanical; (4) sensory; and (5) regenerative. For each class of therapy, we summarize the state of the science, identify gaps in knowledge, and suggest future directions for therapy development. Results Knowledge gaps in all five therapeutic classes can be attributed to the lack of: (1) a unifying conceptual framework for evaluating therapeutic mechanisms of action; (2) large-scale randomized controlled trials; and (3) pharmacodynamic biomarkers that measure subclinical therapeutic effects in early-phase trials. To address these gaps, we propose a precision medicine approach in which clinical trials selectively enroll patients based upon their physiological receptivity to targeted therapies, and therapeutic effects are measured by complementary behavioral, neuroimaging, and electrophysiologic endpoints. Conclusions This personalized approach can be realized through rigorous clinical trial design and international collaboration, both of which will be essential for advancing the development of new therapies and ultimately improving the lives of patients with DoC.
Bibliografia:ObjectType-Article-1
SourceType-Scholarly Journals-1
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scopus-id:2-s2.0-85109768778
The Curing Coma Campaign
ISSN:1541-6933
1556-0961
1556-0961
DOI:10.1007/s12028-021-01227-y