Long-term Effect of tDCS in Patients With Disorders of Consciousness
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|ClinicalTrials.gov Identifier: NCT03114397|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : March 11, 2020
In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected.
This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.
|Condition or disease||Intervention/treatment||Phase|
|Disorder of Consciousness||Device: transcranial direct current stimulation - active Device: transcranial direct current stimulation - sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2022|
Active Comparator: anodal stimulation
Patients will receive anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.
Device: transcranial direct current stimulation - active
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.
Placebo Comparator: sham stimulation
Patients will receive sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.
Device: transcranial direct current stimulation - sham
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.
- Change in the CRS-R total score [ Time Frame: 4 weeks ]Improvement of the CRS-R total score after the end of the anodal session.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114397
|Contact: Aurore Thibaut, PhD||+32 4 366 24 firstname.lastname@example.org|