PatientsVille.com LogoPatientsVille.com

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

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Growth Hormone0.4 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:Sildenafil50 mg by mouth daily

Drug:PlaceboPlacebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Recombinant Growth HormoneDouble blind placebo/Genotropin cross over design for 6 months with cross over at 3 months. Then open label Genotropin from month 6 - 12.

SildenafilDouble blinded placebo/Sildenafil crossover design for 6 months with crossover at month 3. Then open label Sildenafil from months 6-12.

Study Status

Completed

Start Date: December 12, 2014

Completed Date: November 10, 2017

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Performance fatigue as measured by using hand grip dynamometry at baseline

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Randall J Urban, MD

Lead Sponsor: The University of Texas Medical Branch, Galveston

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02114775

Discuss Viagra