Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Growth Hormone, Neuroimaging
Brief summary
The current protocol aims to compare the brain-functioning (fMRI & EEG) and white matter structural integrity (DTI) of persons with mild to severe TBI with and without Growth Hormone deficiency during cognitive tasks; and to examine changes in cognitive and motor performance, EEG/fMRI and white matter integrity associated with growth hormone treatment for twelve months using an open-label design in persons with GH deficiency/insufficiency following mild to severe TBI. To meet this aim, we are in the process of screening 40 persons with mild to severe TBI, ages 18-55, who are at least six months post injury. After screening, 10 persons with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH injections titrated to bring their GH levels into the normal range over the course of twelve months. Treatment will be initiated using rhGH (Genotropin). Subjects with TBI and GHD will be assessed at baseline, 6 months, and 12 months with EEG, fMRI and DTI, and neuropsychological measures. 5 persons with TBI who do not have GHD will be assessed at baseline and at 12 months with EEG, fMRI and DTI, and neuropsychological measures.
Interventions
DRUGGenotropin
Sponsors
Joe Springer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in brain function assessed by functional MRI | baseline and one year | Participants will undergo functional MRI at baseline and one year later to determine brain function after treatment. Data will be presented as the change in brain function over time presented as mean +/- SEM. |
| Change in brain function assessed by electroencephalogram | baseline and one year | Participants will undergo electroencephalograms at baseline and one year later to determine brain function after treatment. Data will be presented as the change in brain function over time presented as mean +/- SEM. |
| Change in white matter structural integrity | baseline and one year | Participants will undergo routine MRI at baseline and one year later. Data will be presented as the change in brain function over time presented as mean +/- SEM. |
Countries
United States
Outcome results
None listed