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

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ClinicalTrials.gov Identifier: NCT01699308
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Joe Springer, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Genotropin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth Hormone and Brain Functioning After Traumatic Brain Functioning
Actual Study Start Date : December 1, 2009
Actual Primary Completion Date : April 1, 2014
Actual Study Completion Date : April 1, 2014

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. Change in brain function assessed by functional MRI [ Time Frame: baseline and one year ]
    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.

  2. Change in brain function assessed by electroencephalogram [ Time Frame: baseline and one year ]
    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.

  3. Change in white matter structural integrity [ Time Frame: baseline and one year ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699308


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
Joe Springer
Investigators
Principal Investigator: J Springer, PhD University of Kentucky

Responsible Party: Joe Springer, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01699308     History of Changes
Other Study ID Numbers: Pfizer/WS935852
09.0874-F1V ( Other Identifier: UK IRB )
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
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