Growth Hormone and Brain Functioning After Traumatic Brain Functioning
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in brain function assessed by functional MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to Severe TBI
- •At Least 6 Months Post Injury
- •Ages 18-55
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Genotropin (Drug)
结局指标
主要结局
Change in brain function assessed by functional MRI
时间窗: 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.
Change in brain function assessed by electroencephalogram
时间窗: 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.
Change in white matter structural integrity
时间窗: 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.
次要结局
未报告次要终点
研究者
Joe Springer
Associate Professor
University of Kentucky