Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 100
Exclusion Criteria
- Coumadin because of the risk of bleeding with daily injections of Recombinant Human Growth Hormone (rhGH) in the growth hormone (GH) arm of the study.
- Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
- Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
- Coumadin because of the risk of bleeding with daily injections of Recombinant Human Growth Hormone (rhGH) in the growth hormone (GH) arm of the study.
- Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
- Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Summary
- Conditions
- Traumatic Brain Injury
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
Three primary outcome measures are proposed: Perceptual fatigue as measured weekly using the Brief Fatigue Inventory (BFI) (59). Performance fatigue as measured at baseline and month 3, 6 and 12 using hand and leg dynamometry. Neuropsychological function as measured at baseline and month 12. Seconda...
Three primary outcome measures are proposed: Perceptual fatigue as measured weekly using the Brief Fatigue Inventory (BFI) (59). Performance fatigue as measured at baseline and month 3, 6 and 12 using hand and leg dynamometry. Neuropsychological function as measured at baseline and month 12. Secondary outcomes will include: Modified 6 minute walk performance as measured at baseline, and month 3, 6 and 12. 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. Sleep quality using the Pittsburgh Sleep Quality Index (PSQI), baseline, and month 3, 6, and 12. Multidimensional fatigue using Multidimensional Fatigue Symptom Inventory (MFSI) at baseline, and month 3, 6 and 12. 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. Physical Activity, measured daily using accelerometry. Cerebral blood oxygen saturation measured at baseline and month 12. Leg blood flow measured at baseline, and month 3, 6 and 12. Blood Hormones at baseline and month 3, 6 and 12. Characterization of brain tissue using structural, "resting state" and diffusion functional MR at baseline and month 3, 6, and 12. Indirect calorimetry measured at baseline and month 3, 6 and 12.
Exclusion Criteria
- Coumadin because of the risk of bleeding with daily injections of Recombinant Human Growth Hormone (rhGH) in the growth hormone (GH) arm of the study.
- Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
- Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
- Coumadin because of the risk of bleeding with daily injections of Recombinant Human Growth Hormone (rhGH) in the growth hormone (GH) arm of the study.
- Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
- Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Tracking Information
- NCT #
- NCT02114775
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Randall J Urban, MD University of Texas Principal Investigator: Melinda Sheffield-Moore, PhD University of Texas Principal Investigator: Brent Masel, MD Transitional Learning Center
- Randall J Urban, MD University of Texas Principal Investigator: Melinda Sheffield-Moore, PhD University of Texas Principal Investigator: Brent Masel, MD Transitional Learning Center
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