Clinical trial NCT01699308: Growth Hormone and Brain Functioning After Traumatic Brain Injury
Official title: Growth Hormone and Brain Functioning After Traumatic Brain Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Growth Hormone
Neuroimaging
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in brain function assessed by functional MRI
timeFrame: baseline and one year
measure: Change in brain function assessed by electroencephalogram
timeFrame: baseline and one year
measure: Change in white matter structural integrity
timeFrame: baseline and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: J Springer, PhD
role: PRINCIPAL_INVESTIGATOR
References: