Insomnia
Conditions
Keywords
concussion, gabapentin, neurontin, insomnia
Brief summary
In this open-label, pilot study the investigators will be assessing gabapentin's effects on insomnia and other concussion-related symptoms in patients with a recent concussion experiencing insomnia.
Interventions
DRUGGabapentin
300mg capsules by mouth
Sponsors
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Head trauma causing concussion with either no loss of consciousness (LOC) or LOC \< 30 minutes within previous 2 weeks. 2. ISS score at Baseline of \> 14. 3. PCSS score at Baseline \> 5. 4. If brain imaging has been checked, there was no intracerebral hemorrhage noted. 5. Glasgow Coma Scale score of 15 at Baseline. 6. Age of at least 14 years old. 7. Has not taken gabapentin or pregabalin any time since concussion and has no history of intolerance to gabapentin or pregabalin. 8. Has not taken any sleeping pills for previous 2 nights and agrees not to take any for the next 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index from Baseline to 1 week | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Change in Post Concussion Symptom Scale score from Baseline to 1 week | 1 week |
Countries
United States
Outcome results
None listed