Growth Hormone and Brain Functioning After Traumatic Brain Injury
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.