Traumatic Brain Injury
Conditions
Keywords
mild traumatic brain injury, growth hormone, fatigue, sildenafil, neurology
Brief summary
The overall goal is to determine whether perceptual or performance fatigue can be reduced in MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover fashion based upon GH status. A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.
Detailed description
Three primary outcome measures are proposed: 1. Perceptual fatigue as measured weekly using the Brief Fatigue Inventory (BFI) (59). 2. Performance fatigue as measured at baseline and month 3, 6 and 12 using hand and leg dynamometry. 3. Neuropsychological function as measured at baseline and month 12. Secondary outcomes will include: 1. Modified 6 minute walk performance as measured at baseline, and month 3, 6 and 12. 2. Mood and quality of life using the Profile of Mood States, Quality of Life Assessment of GH Deficiency in Adults questionnaire, and a grief assessment (60) (POMS), measured at baseline, and month 3, 6, and 12. 3. Sleep quality using the Pittsburgh Sleep Quality Index (PSQI), baseline, and month 3, 6, and 12. 4. Multidimensional fatigue using Multidimensional Fatigue Symptom Inventory (MFSI) at baseline, and month 3, 6 and 12. 5. Skeletal muscle mass, as derived from lean body mass determinations, using dual energy X-ray absorptiometry (iDEXA) at baseline, and month 3, 6, and 12. 6. Physical Activity, measured daily using accelerometry. 7. Cerebral blood oxygen saturation measured at baseline and month 12. 8. Leg blood flow measured at baseline, and month 3, 6 and 12. 9. Blood Hormones at baseline and month 3, 6 and 12. 10. Characterization of brain tissue using structural, resting state and diffusion functional MR at baseline and month 3, 6, and 12. 11. Indirect calorimetry measured at baseline and month 3, 6 and 12.
Interventions
DRUGGrowth Hormone
0.4 mg/day injected subcutaneously for one month then increased to 0.6 mg/day for two months during crossover phase. After crossover phase, 0.6 mg/day for six months
DRUGSildenafil
50 mg by mouth daily
DRUGPlacebo
Placebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Male or female with a diagnosis of mild TBI and 6 month post-injury. Age 18 to 60 years. Complaint of fatigue, with score of 3 or greater on questions 1, 2, or 3 of the Brief Fatigue Inventory.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance fatigue as measured by using hand grip dynamometry at baseline | baseline | Hand grip exercises will be used to measure performance fatigue at baseline |
| Performance fatigue as measured by using hand grip dynamometry at 3 months | 3 months | Hand grip exercises will be used to measure performance fatigue after 3 months of study intervention |
| Performance fatigue as measured by using hand grip dynamometry at 6 months | 6 months | Hand grip exercises will be used to measure performance fatigue after 6 months of study intervention |
| Performance fatigue as measured by using hand grip dynamometry at 12 months | 12 months | Hand grip exercises will be used to measure performance fatigue after 12 months of study intervention |
| Performance fatigue as measured by using leg dynamometry at baseline | baseline | Leg exercises will be used to measure performance fatigue at baseline |
| Performance fatigue as measured by using leg dynamometry at 3 months | 3 months | Leg exercises will be used to measure performance fatigue after 3 months of study intervention. |
| Performance fatigue as measured by using leg dynamometry at 6 months | 6 months | Leg exercises will be used to measure performance fatigue after 6 months of study intervention. |
| Performance fatigue as measured by using leg dynamometry at 12 months | 12 months | Leg exercises will be used to measure performance fatigue after 12 months of study |
Countries
United States
Outcome results
None listed