Clinical Trial: tDCS in MCS: Repeated Stimulations

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Repeated tDCS in Chronic Minimally Conscious State Patients : a Sham-controlled Randomized Double Blind Study

Brief Summary:

In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).

2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.


Detailed Summary:

Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the left prefrontal dorsolateral cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.

Researchers expected to see an improvement of the CRS-r total score at the end of the anodal session and that this improvement persists for a week.


Sponsor: University Hospital of Liege

Current Primary Outcome: Change in the CRS-R total score [ Time Frame: after each stimulation and one week later for anodal and sham sessions (total: 1 month) ]

Improvement of the CRS-R total score after the end of the anodal session and one week later but no change for the sham session.


Original Primary Outcome: Same as current

Current Secondary Outcome: Influence of the time since insult [ Time Frame: one month ]

Influence of the time since insult of the results. We expected that the longer a patient is in MCS, the lower is his/her improvement after the tDCS session.


Original Secondary Outcome: Same as current

Information By: University Hospital of Liege

Dates:
Date Received: December 18, 2013
Date Started: February 2013
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017