Growth Hormone and Brain Functioning After Traumatic Brain Injury
Information source: University of Kentucky
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury
Intervention: Genotropin (somatropin) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Kentucky
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.
Clinical Details
Official title: Growth Hormone and Brain Functioning After Traumatic Brain Functioning
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: To compare the brain-functioning (fMRI & EEG) and white matter structural integrity (DTI) of persons with mild to severe TBI with and without GH deficiency during cognitive tasks.
Secondary outcome: To examine changes in cognitive and motor performance, EEG/fMRI, white matter integrity, associated with growth hormone treatment for one year using an open-label design in persons with GH deficiency/insufficiency following mild to severe TBI.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
University of Kentucky, Lexington, Kentucky 40502, United States; Recruiting
Walter M High, Ph.D., Phone: 859-257-4888, Email: walter.high@uky.edu
Shonna L Jenkins, M.S., Phone: 859.233.4511, Ext: 2575, Email: shonna.jenkins@uky.edu
Walter M High, Ph.D., Principal Investigator
Additional Information
Starting date: December 2009
Last updated: May 13, 2013
|
