Growth Hormone and Brain Functioning After Traumatic Brain Injury

Joe Springer15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in brain function assessed by functional MRI

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.

Time frame: baseline and one year

Change in brain function assessed by electroencephalogram

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.

Time frame: baseline and one year

Change in white matter structural integrity

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.

Time frame: baseline and one year

Growth Hormone and Brain Functioning After Traumatic Brain Injury

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes