tDCS in MCS: Repeated Stimulations

N/ACompletedNCT02019615

University of Liege20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)

Interventions

transcranial direct current stimulationDEVICE

anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session

Eligibility

Sex: ALLMin age: 15 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * post comatose patients * patients in minimally conscious state * patients with stable condition * patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan) Exclusion Criteria: * premorbid neurology antecedent * patients in coma or vegetative state * patients \< 3 months after the acute brain injury * patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

Locations (1)

University of Liège

Liège, Liège, Belgium

Outcomes

Primary Outcomes

Change in the CRS-R total score

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.

Time frame: after each stimulation and one week later for anodal and sham sessions (total: 1 month)

Secondary Outcomes

Influence of the time since insult

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.

Time frame: one month

Data from ClinicalTrials.gov

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