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

October 1, 2012
May 13, 2013
December 2009
April 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01699308 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Growth Hormone and Brain Functioning After Traumatic Brain Injury
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Traumatic Brain Injury
Drug: Genotropin (somatropin)
  • 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.
    Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
United States
 
NCT01699308
Pfizer/WS935852, 09.0874-F1V
Yes
Walter High Jr., University of Kentucky
University of Kentucky
Not Provided
Not Provided
University of Kentucky
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP