Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Brief Summary

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Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown.

This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.

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Detailed Description

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This study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tDCS intensity, totalizing a number of 10X2 stimulation sessions of 20 minutes each).

Conditions

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Disorder of Consciousness Minimally Conscious State Vegetative State Cognitive Impairment

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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2 mA anodal tDCS stimulation

Anodal tDCS stimulation at 2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks

Group Type EXPERIMENTAL

transcranial direct current stimulation (tDCS) / Comparison of current intensities

Intervention Type DEVICE

0.2 mA anodal tDCS stimulation

Anodal tDCS stimulation at 0.2 mA applied to the left dorsolateral prefrontal during 20 minutes five days a week for two consecutive weeks

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS) / Comparison of current intensities

Intervention Type DEVICE

Interventions

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transcranial direct current stimulation (tDCS) / Comparison of current intensities

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities)
* Patients with stable clinical examination
* Age between 18 and 80 years
* Brain injury confirmed by cerebral imaging (MRI or TDM)
* Disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)