Growth Hormone and Brain Functioning After Traumatic Brain Injury

NCT ID: NCT01699308

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-01
• Study Completion Date: 2014-04-01

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genotropin

10 persons with TBI and GHD will receive daily rhGH injections titrated to bring their GH levels into the normal range for one year. Treatment is initiated using Genotropin (rhGH) at an initial daily dose of 200mcg/day subcutaneously with a titration schedule calling for an increase in daily dosage by 200 mcg every two months until the target daily dose, 600 mcg/day, is achieved. The 10 GHD subjects will be assessed at baseline with EEG, fMRI and DTI and neuropsychological measures, again at 6 months, and a third time at 12 months.

Group Type: EXPERIMENTAL

Genotropin

Intervention Type: DRUG

Control

5 demographically-matched TBI with normal GH subjects will be assessed at baseline (with EEG, fMRI and DTI, and neuropsychological measures) and at 12 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Genotropin

Intervention Type: DRUG

Other Intervention Names

somatropin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joe Springer

OTHER

Sponsor Role: lead

Responsible Party

Joe Springer

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

J Springer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

09.0874-F1V

Identifier Type: OTHER

Identifier Source: secondary_id

Pfizer/WS935852

Identifier Type: -

Identifier Source: org_study_id