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

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

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-12-24

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.

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Detailed Description

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Conditions

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Disorder of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation - active

Intervention Type DEVICE

transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.

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.

Group Type PLACEBO_COMPARATOR

transcranial direct current stimulation - sham

Intervention Type DEVICE

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.

Interventions

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transcranial direct current stimulation - active

transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.

Intervention Type 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.

Intervention Type DEVICE

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).

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No