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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Walter High Jr., University of Kentucky
ClinicalTrials.gov Identifier:
NCT01699308
First received: October 1, 2012
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Drug: Genotropin (somatropin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Growth Hormone and Brain Functioning After Traumatic Brain Functioning

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • To compare the brain-functioning (fMRI & EEG) and white matter structural integrity (DTI) of persons with mild to severe TBI with and without GH deficiency during cognitive tasks. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine changes in cognitive and motor performance, EEG/fMRI, white matter integrity, associated with growth hormone treatment for one year using an open-label design in persons with GH deficiency/insufficiency following mild to severe TBI. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 rhGH (Genotropin) 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 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699308

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40502
Contact: Walter M High, Ph.D.    859-257-4888    walter.high@uky.edu   
Contact: Shonna L Jenkins, M.S.    859.233.4511 ext 2575    shonna.jenkins@uky.edu   
Principal Investigator: Walter M High, Ph.D.         
Sponsors and Collaborators
University of Kentucky
  More Information

No publications provided

Responsible Party: Walter High Jr., Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01699308     History of Changes
Other Study ID Numbers: Pfizer/WS935852, 09.0874-F1V
Study First Received: October 1, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Traumatic Brain Injury
Growth Hormone
Neuroimaging

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014