Status:
WITHDRAWN
Vagus Nerve Stimulation to Augment Recovery From Minimally Conscious or Persistently Vegetative States After Traumatic Brain Injury
Lead Sponsor:
VA New York Harbor Healthcare System
Conditions:
Minimally Conscious States Due to Traumatic Brain Injury
Persistently Vegetative States Due to Traumatic Brain Injury
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Traumatic brain injury has a high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing neurons to disconn...
Eligibility Criteria
Inclusion
- Age between 18 and 60
- greater than 12 months from a moderate to severe traumatic brain injury
- Disability Rating Scale score of 18 to 29
- with or without concurrent seizure activity
- Eligible for care in the VA system
Exclusion
- Anoxic mechanism of brain injury (eg prolonged arrest)
- Untreated hydrocephalus
- Elevated intracranial pressure
- Systemic issues precluding surgery or 18 months survival
- Traumatic injuries precluding surgery or 18 months survival
- Retained shrapnel or other metal contraindicating MRI
- Prior vagotomy
- Sleep apnea
- Myocardial infarction, arrhythmia
- History of cardiac conduction abnormality
- Pregnancy or intent to become pregnant
- Pre-existing CNS disease
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01260090
Start Date
January 1 2011
End Date
October 1 2013
Last Update
April 27 2023
Active Locations (1)
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1
Manhattan Va NYHHCS
New York, New York, United States, 10010