Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study
Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Pankaj Bansal, MD
- 电话号码：9055748515
- 邮箱：bansalp@hhsc.ca
学习地点
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Ontario
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Hamilton、Ontario、加拿大
- Hamilton Health Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：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.
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Participants will initially receive amantadine at the starting dose of 50mg twice daily either by mouth or feeding tube.
The dosage will increase every week by 50mg twice daily (100mg total dose increase) up to the target dose of 200mg twice daily.
These are the usual doses and rate of increase that are offered to patients with brain injury.
其他名称：
Participants will initially receive a baseline MRI Tractography scan.
The size of RAS fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Radiographic Changes
大体时间：At baseline and ninety days or at time of discharge from hospital if occurs earlier.
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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.
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At baseline and ninety days or at time of discharge from hospital if occurs earlier.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Improvement
大体时间：At ninety days or at time of discharge from hospital if occurs earlier.
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Disability Rating Scale Score (at enrolment and at completion of the study).
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At ninety days or at time of discharge from hospital if occurs earlier.
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合作者和调查者
调查人员
- 首席研究员：Pankaj E Bansal, MD、Hamilton Health Sciences Corporation
- 首席研究员：Seyed Hosseini, MD、Hamilton Health Sciences Corporation
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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