tDCS on Precuneus in MCS: Repeated Stimulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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

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Detailed Description

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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 precuneus 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 5 days 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 5 days.

Conditions

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Patients in Minimally Conscious State After a Severe Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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anodal stimulation

Patients received anodal tDCS (on the precuneus ) every day for 5 days (tDCS of 2mA during 20minutes). A CRS-R is performed at baseline (before the first stimulation) and after each tDCS.

A final CRS-R is performed 5 days after the end of the session to assess the potential long term effects of the tDCS.

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.

sham stimulation

Patients received sham tDCS (5 secondes of stimulation) every day for 5 days. A CRS-R is performed at baseline (before the first stimulation) and after each tDCS. A final CRS-R is performed 5 days after the end of the session.

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.

Interventions

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transcranial direct current stimulation

anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.

Intervention Type DEVICE

Eligibility Criteria

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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 \< 1 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)

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No