Zolpidem trial in traumatic brain injury
Phase 2
- Conditions
- Vegetative life after traumatic brain injury.Intracranial injury
- Registration Number
- IRCT20130310012776N5
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
being in vegetative state due to trauma for more than 4-8 months, in a medically stable condition
no severe complications or other comorbidities in addition to brain damage
good nutritional status (BMI>18 kg/m2)
accepting to participate in the study by patients' family or guardian
Exclusion Criteria
Allergic reaction to zolpidem
Indication for any additional surgical or medical intervention during zolpidem treatment
poor cooperation for SPECT imaging
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Motor part of GCS. Timepoint: at biggining and two weeks later after treatment. Method of measurement: physical exam by physician.;Glascow outcome scale extended (GOSE). Timepoint: at biggining and two weeks later after treatment. Method of measurement: physical exam by physician.
- Secondary Outcome Measures
Name Time Method