Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Radiographic Changes
研究概览
简要总结
This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.
详细描述
Primary Aim:
To determine the size of the RAS tracts as measured by MRI tractography. Specifically, the investigators will be measuring the fiber tracts that project through the posterior thalamus. The RAS is involved in mediating arousal and consciousness. The size of fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days. It is hypothesized that treatment will result in an increase in the size of these fiber tracts.
As a pilot study, the investigators will be determining the feasibility of recruiting and retaining patients in this type of study. This will allow the clarification and understanding of the technical standards for MRI tractography related to the assessment of the reticular activating system.
Secondary Aim:
To determine and monitor changes in function following acquired brain injury as measured by the Disability Rating Scale (DRS) score. The DRS score will be obtained prior to initiating treatment and at termination of the study. It is hypothesized that treatment with amantadine in addition to standard medical treatment, will be associated with an improvement in function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years - 65 years
- •Nonpenetrating acquired brain injury (ABI)
- •Persistent vegetative or minimally conscious state (as indicated by DRS score greater than 11)
- •Consent from substitute decision maker
排除标准
- •Contraindication to MRI (such as metal in the body, pacemaker, implanted nerve stimulator)
- •Anticipated neurosurgical intervention
- •Medical instability including uncontrolled hypertension, fever, or infection
- •Seizure disorder prior to acquired brain injury or uncontrolled seizures subsequent to acquired brain injury
- •Parkinson's disease
- •History of heart failure or pre-existing peripheral oedema
- •History of eczematoid dermatitis
- •History of angle-closure glaucoma
- •History of neuroleptic malignant syndrome
- •Current treatment with Amantadine
- •Impairment related to other neurologic disease other than ABI
- •Allergy to Amantadine
- •Pregnancy or lactation
- •Impairment of renal function (creatinine clearance less than 60ml/min)
研究组 & 干预措施
Treatment and MRI scanning
After informed consent has been obtained, the subjects will be examined by a physician and assigned a Disability Ratings Scale (DRS) score. Subjects will undergo MRI tractography study, which does not require the administration of contrast. All participants will receive oral amantadine at escalating doses to ensure tolerance (50mg twice daily for 7 days, then 100mg twice daily for 1 week, then 150mg twice daily, then 200mg twice daily). The usual length of stay on the inpatient brain injury program is ninety days. The MRI tractography study and DRS score will be repeated near the time of discharge or ninety days from enrollment.
干预措施: Amantadine (Drug)
Treatment and MRI scanning
After informed consent has been obtained, the subjects will be examined by a physician and assigned a Disability Ratings Scale (DRS) score. Subjects will undergo MRI tractography study, which does not require the administration of contrast. All participants will receive oral amantadine at escalating doses to ensure tolerance (50mg twice daily for 7 days, then 100mg twice daily for 1 week, then 150mg twice daily, then 200mg twice daily). The usual length of stay on the inpatient brain injury program is ninety days. The MRI tractography study and DRS score will be repeated near the time of discharge or ninety days from enrollment.
干预措施: MRI Tractography Study (Procedure)
结局指标
主要结局
Radiographic Changes
时间窗: At baseline and ninety days or at time of discharge from hospital if occurs earlier.
MRI Tractography will be performed to measure the size the of reticular activating system fiber tracts. Specifically, the tracts that project through the posterior thalamus.
次要结局
- Functional Improvement(At ninety days or at time of discharge from hospital if occurs earlier.)