Long-term Effect of tDCS in Patients With Disorders of Consciousness

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Device: transcranial direct current stimulation - active
* Device: transcranial direct current stimulation - sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CNS medication stable for at least a week Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week). Between 3 and 24 months post injury Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC) Exclusion Criteria: Craniotomies encompassing the frontal region (electrodes location) VPS under the stimulated area (prefrontal cortex) Pacemaker Metallic cerebral implant Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anodal stimulation<br>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<br>* transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.<br>|
| Placebo Comparator: sham stimulation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the CRS-R total score | Improvement of the CRS-R total score after the end of the anodal session. | 4 weeks |