NCT02114775

Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)

Growth Hormone or Sildenafil as Therapies for Fatigue in MTBI

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Growth 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
DRUG	Sildenafil	50 mg by mouth daily
DRUG	Placebo	Placebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study

Timeline

• Start date: 2014-12-12
• Primary completion: 2017-11-10
• Completion: 2017-11-10
• First posted: 2014-04-15
• Last updated: 2018-02-05

Locations

1 site across 1 country: United States