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

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Growth Hormone

Sildenafil

Placebo

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring mild traumatic brain injury, growth hormone, fatigue, sildenafil, neurology

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Significant heart, liver, kidney, blood or respiratory disease.
Active coronary disease.
Pregnancy.
Alcohol or drug abuse.
Unable to walk unassisted.
Diabetes mellitus and anterior pituitary abnormalities diagnosed upon screening.
Premorbid history of psychiatric disorder.
Premorbid history of head trauma.

Exclusion criteria (sildenafil/placebo group)

Use of nitrates.
Use of alpha blockers.
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).
Peripheral vascular disease.
Use of a phosphodiesterase 5 inhibitor.

Exclusion criteria (growth hormone/placebo group)

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 who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
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.

Sites / Locations

University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Recombinant Growth Hormone

Sildenafil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Performance fatigue as measured by using hand grip dynamometry at 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

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

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

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

Leg exercises will be used to measure performance fatigue at baseline

Performance fatigue as measured by using leg dynamometry at 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

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

Leg exercises will be used to measure performance fatigue after 12 months of study

Secondary Outcome Measures

Full Information

NCT ID

NCT02114775

First Posted

January 31, 2014

Last Updated

February 1, 2018

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT02114775

Brief Title

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

Official Title

Growth Hormone or Sildenafil as Therapies for Fatigue in MTBI

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

December 12, 2014 (Actual)

Primary Completion Date

November 10, 2017 (Actual)

Study Completion Date

November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

mild traumatic brain injury, growth hormone, fatigue, sildenafil, neurology

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recombinant Growth Hormone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sildenafil

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Growth Hormone

Other Intervention Name(s)

Genotropin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Other Intervention Name(s)

Viagra

Intervention Description

50 mg by mouth daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Performance fatigue as measured by using hand grip dynamometry at baseline

Description

Hand grip exercises will be used to measure performance fatigue at baseline

Time Frame

baseline

Title

Performance fatigue as measured by using hand grip dynamometry at 3 months

Description

Hand grip exercises will be used to measure performance fatigue after 3 months of study intervention

Time Frame

3 months

Title

Performance fatigue as measured by using hand grip dynamometry at 6 months

Description

Hand grip exercises will be used to measure performance fatigue after 6 months of study intervention

Time Frame

6 months

Title

Performance fatigue as measured by using hand grip dynamometry at 12 months

Description

Hand grip exercises will be used to measure performance fatigue after 12 months of study intervention

Time Frame

12 months

Title

Performance fatigue as measured by using leg dynamometry at baseline

Description

Leg exercises will be used to measure performance fatigue at baseline

Time Frame

baseline

Title

Performance fatigue as measured by using leg dynamometry at 3 months

Description

Leg exercises will be used to measure performance fatigue after 3 months of study intervention.

Time Frame

3 months

Title

Performance fatigue as measured by using leg dynamometry at 6 months

Description

Leg exercises will be used to measure performance fatigue after 6 months of study intervention.

Time Frame

6 months

Title

Performance fatigue as measured by using leg dynamometry at 12 months

Description

Leg exercises will be used to measure performance fatigue after 12 months of study

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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) Significant heart, liver, kidney, blood or respiratory disease. Active coronary disease. Pregnancy. Alcohol or drug abuse. Unable to walk unassisted. Diabetes mellitus and anterior pituitary abnormalities diagnosed upon screening. Premorbid history of psychiatric disorder. Premorbid history of head trauma. Exclusion criteria (sildenafil/placebo group) Use of nitrates. Use of alpha blockers. 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). Peripheral vascular disease. Use of a phosphodiesterase 5 inhibitor. Exclusion criteria (growth hormone/placebo group) 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 who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randall J Urban, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Melinda Sheffield-Moore, PhD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Brent Masel, MD

Organizational Affiliation

Transitional Learning Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

12. IPD Sharing Statement

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

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