Growth Hormone and Brain Functioning After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— GH  

Official title:

Growth Hormone and Brain Functioning After Traumatic Brain Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699308
• Other study ID #: Pfizer/WS935852
• Secondary ID: 09.0874-F1V
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2009
• Est. completion date: April 1, 2014

Study information

• Verified date: September 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 1, 2014
• Est. primary completion date: April 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Genotropin

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Joe Springer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and one year
Primary	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.	baseline and one year
Primary	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.	baseline and one year