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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Genotropin
Sponsored by
Joe Springer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Growth Hormone, Neuroimaging

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Genotropin

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2012
Last Updated
September 6, 2018
Sponsor
Joe Springer
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1. Study Identification

Unique Protocol Identification Number
NCT01699308
Brief Title
Growth Hormone and Brain Functioning After Traumatic Brain Injury
Acronym
GH
Official Title
Growth Hormone and Brain Functioning After Traumatic Brain Functioning
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2009 (Actual)
Primary Completion Date
April 1, 2014 (Actual)
Study Completion Date
April 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joe Springer

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Growth Hormone, Neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genotropin
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Genotropin
Other Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Change in brain function assessed by functional MRI
Description
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.
Time Frame
baseline and one year
Title
Change in brain function assessed by electroencephalogram
Description
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.
Time Frame
baseline and one year
Title
Change in white matter structural integrity
Description
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.
Time Frame
baseline and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Springer, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Growth Hormone and Brain Functioning After Traumatic Brain Injury

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