Growth Hormone and Brain Functioning After Traumatic Brain Injury (GH)

Growth Hormone and Brain Functioning After Traumatic Brain Functioning

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 Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: Genotropin

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40502
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Genotropin; Other Names: somatropin
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Joe Springer
• Investigators: Principal Investigator: J Springer, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Growth Hormone; Neuroimaging; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: Pfizer/WS935852; 09.0874-F1V (Other Identifier: UK IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No