Growth Hormone and Brain Functioning After Traumatic Brain Injury (GH)
Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Growth Hormone, Neuroimaging
Eligibility Criteria
Inclusion Criteria:
- Mild to Severe TBI
- At Least 6 Months Post Injury
- Ages 18-55
Exclusion Criteria:
- Patients Taking Anticoagulants, Anticonvulsants, Cyclosporine, Corticosteroids, and Sex Steroids
- History of Hepatitis B or C
- History of Symptomatic Coronary Disease or Congestive Heart Failure
- Pre-Existing Neurologic Disease such as Epilepsy, Alzheimer's Disease, Multiple Sclerosis, Brain Tumors, etc.
- Obesity (BMI > 30)
- Pregnant or Lactating Females
- Penetrating Traumatic Brain Injury
- Having a Pacemaker
- Diabetes and Diabetic Retinopathy
- Serious Psychiatric Conditions (e.g., Schizophrenia, Bipolar Disorder, Major Depressive Disorder, etc.)
- Patients with Language Problems such as Aphasia
- Any Sign of Neoplastic Activity
- Active Malignancies
- Three-Fold Elevation of Liver Function Tests (ALP, ALT, AST)
- Partially Deficient in Both Cortisol and Thyroid
- Fully Deficient in Either Cortisol and Thyroid
- Patients with Claustrophobia
- Metal in the Body that Cannot be Removed (especially in the head)
- Amputations on Upper Body Limbs
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Genotropin
Control
10 persons with TBI and GHD will receive daily rhGH injections titrated to bring their GH levels into the normal range for one year. Treatment is initiated using Genotropin (rhGH) at an initial daily dose of 200mcg/day subcutaneously with a titration schedule calling for an increase in daily dosage by 200 mcg every two months until the target daily dose, 600 mcg/day, is achieved. The 10 GHD subjects will be assessed at baseline with EEG, fMRI and DTI and neuropsychological measures, again at 6 months, and a third time at 12 months.
5 demographically-matched TBI with normal GH subjects will be assessed at baseline (with EEG, fMRI and DTI, and neuropsychological measures) and at 12 months.