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Completed

NCT Number: NCT01699308

Growth Hormone and Brain Functioning After Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40502, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genotropin

Drug

Other names: somatropin

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Joe Springer

Other

Registry information

Official study title

Growth Hormone and Brain Functioning After Traumatic Brain Functioning

Acronym: GH

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 3, 2012
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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