Traumatic Brain Injury
Conditions
Keywords
perception of time, traumatic brain injury, amantadine
Brief summary
The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task. Approximately 16 individuals with traumatic brain injury are expected to participate in this study. Subject participation is expected to last up to 8 weeks with 16 study visits.
Interventions
DRUGamantadine
amantadine twice daily
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 55 inclusive. History of post-MVA close head TBI. Female subjects must use an acceptable method of contraception during entire study. Acceptable methods of contraception are: history of surgical sterility, postmenopausal status, hormonal contraceptives, or accepted barrier devices (i.e., male/female condom, diaphragm, cervical cap, intrauterine device).
Exclusion criteria
* Current or past history of major psychiatric disorder (schizophrenia, bipolar disorder, major depressive disorder) * Substance use disorder * Current or past history of serious chronic medical condition (pulmonary (lung), cardiovascular (heart), hepato-renal (liver-kidney) disease, diabetes) * Seizures * Smoking one or more packs of cigarettes per day * If you are pregnant or breastfeeding, or plan to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the Interval Bisection Timing Task. | 12 -16 months |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). | 12-16 moths |
Countries
United States
Outcome results
None listed