Growth Hormone and Brain Functioning After Traumatic Brain Injury

NCT01699308 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: Pfizer/WS93585209.0874-F1V
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Traumatic Brain Injury; Growth Hormone; Neuroimaging

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Genotropin

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Genotropin DRUG

Also known as: somatropin

Genotropin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild to Severe TBI
• At Least 6 Months Post Injury
• Ages 18-55

You may not qualify if:

• 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

Sponsors & Collaborators

• Joe Springer: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40502, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• J Springer, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: December 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)