Status:
COMPLETED
Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State
Lead Sponsor:
Methodist Rehabilitation Center
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Traumatic Brain Injury
Posttraumatic Confusional State
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, pat...
Detailed Description
Patients with TBI who require inpatient rehabilitation are frequently confused at the time of admission for rehabilitation. Our investigations of confusion conducted as part of the TBIMSM have clarifi...
Eligibility Criteria
Inclusion
- Acute Traumatic Brain Injury (≤90 days postinjury)
- Responsive (not fulfilling criteria for Minimally Conscious State)
- Meet PTCS criteria on 2 consecutive examinations (as determined by the Confusion Assessment Protocol)
- Initial neurorehabilitation hospital admission
- Anticipated ≥2 week length-of-stay after meeting PTCS criteria
Exclusion
- Preexisting seizure disorder
- Prior history of hospitalization for psychiatric condition
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00693121
Start Date
April 1 2003
End Date
March 1 2019
Last Update
October 18 2023
Active Locations (1)
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1
Methodist Rehabilitation Center
Jackson, Mississippi, United States, 39216