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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.
Three primary outcome measures are proposed:
Secondary outcomes will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Growth Hormone | Active Comparator | Double blind placebo/Genotropin cross over design for 6 months with cross over at 3 months. Then open label Genotropin from month 6 - 12. |
|
| Sildenafil | Active Comparator | Double blinded placebo/Sildenafil crossover design for 6 months with crossover at month 3. Then open label Sildenafil from months 6-12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth Hormone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance fatigue as measured by using hand grip dynamometry at baseline | Hand grip exercises will be used to measure performance fatigue at baseline | 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 | 3 months |
| 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 | 6 months |
| 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 | 12 months |
| Performance fatigue as measured by using leg dynamometry at baseline | Leg exercises will be used to measure performance fatigue at baseline | 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. | 3 months |
| 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. |
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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)
Exclusion criteria (sildenafil/placebo group)
Exclusion criteria (growth hormone/placebo group)
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| Name | Affiliation | Role |
|---|---|---|
| Randall J Urban, MD | University of Texas | Principal Investigator |
| Melinda Sheffield-Moore, PhD | University of Texas | Principal Investigator |
| Brent Masel, MD | Transitional Learning Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Sildenafil | Drug | 50 mg by mouth daily |
|
|
| Placebo | Drug | Placebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study |
|
| 6 months |
| 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 | 12 months |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |