Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)
Information source: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury
Intervention: Growth Hormone (Drug); Sildenafil (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: The University of Texas Medical Branch, Galveston Official(s) and/or principal investigator(s):
Randall J Urban, MD, Principal Investigator, Affiliation: University of Texas
Melinda Sheffield-Moore, PhD, Principal Investigator, Affiliation: University of Texas
Brent Masel, MD, Principal Investigator, Affiliation: Transitional Learning Center
Overall contact:
Charles Gilkison, NP, Phone: 409-772-2065, Email: cgilkiso@utmb.edu
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.
Clinical Details
Official title: Growth Hormone or Sildenafil as Therapies for Fatigue in MTBI
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: Performance fatigue as measured by using hand and leg dynamometry.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Exclusion Criteria:
Exclusion criteria (general)
1. Significant heart, liver, kidney, blood or respiratory disease.
2. Active coronary disease.
3. Pregnancy.
4. Alcohol or drug abuse.
5. Unable to walk unassisted.
6. Diabetes mellitus and anterior pituitary abnormalities diagnosed upon screening.
7. Premorbid history of psychiatric disorder.
8. Premorbid history of head trauma.
Exclusion criteria (sildenafil/placebo group)
1. Use of nitrates.
2. Use of alpha blockers.
3. Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90. This
range is smaller than the acceptable range stated in the prescribing information for
sildenafil (>90/50 and <170/110).
4. Peripheral vascular disease.
5. Use of a phosphodiesterase 5 inhibitor.
Exclusion criteria (growth hormone/placebo group)
1. 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.
2. Subjects who are deficient in cortisol or thyroid at screening will be excluded until
hormone abnormalities have been corrected.
3. 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.
Locations and Contacts
Charles Gilkison, NP, Phone: 409-772-2065, Email: cgilkiso@utmb.edu
University of Texas Medical Branch, Galveston, Texas 77555, United States; Recruiting
Charles Gilkison, NP, Phone: 409-772-2065, Email: cgilkiso@utmb.edu
Kate Randolph, BS, Phone: 409-772-8126, Email: kmrandol@utmb.edu
Randall Urban, MD, Principal Investigator
Melinda Sheffield-Moore, PhD, Principal Investigator
Additional Information
Starting date: March 2015
Last updated: June 18, 2015
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