The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements

Hadassah Medical Organization0 个研究点开始时间: 2011年10月最近更新: 2015年9月22日

适应症

试验速览

阶段: 1 期
状态: 撤回
发起方: Hadassah Medical Organization
主要终点: change in the awareness status of the patients.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Chronic vegetative patients

排除标准

•Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy

结局指标

主要结局

change in the awareness status of the patients.

时间窗: 3-6 months

Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation.

次要结局

change in the awareness status of the patients.(1 month following the end of the trial)

研究者

发起方

Hadassah Medical Organization

申办方类型

Other

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