Clinical Trial: The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State

Brief Summary: The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.

Detailed Summary:
Sponsor: Hadassah Medical Organization

Current Primary Outcome: consciousness level measured clinically [ Time Frame: 6 months ]

Each patient will undergo a behavioral assessment (using the Coma Recovery Scale Revised) before treatment and every 2 weeks during the treatment period as well as 3 months following the end of the treatment. Complete blood counts, electrolytes, liver function tests, renal function tests and ECG will be performed every two weeks.


Original Primary Outcome: consciousness level measured clinically and by functional MRI

Current Secondary Outcome: Functional magnetic resonance imaging of cortical activity [ Time Frame: 6 months ]

3 scans will be performed: before treatment, after three months of treatment and 3 months after cessation of treatment. Scanning sessions will include a hierarchical auditory paradigm, an imagery task and resting state fMRI


Original Secondary Outcome: long lasting effects of the drug

Information By: Hadassah Medical Organization

Dates:
Date Received: September 21, 2011
Date Started: September 2012
Date Completion: October 2018
Last Updated: August 30, 2015
Last Verified: August 2015