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

Not Applicable

Completed

• Conditions: Disorder of Consciousness
• Interventions: Device: transcranial direct current stimulation - active; Device: transcranial direct current stimulation - sham

• Registration Number: NCT03114397
• Lead Sponsor: University of Liege

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-09-01
• Primary Completion: 2021-12-24
• Study Completion: 2021-12-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anodal stimulation	transcranial direct current stimulation - active	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.
sham stimulation	transcranial direct current stimulation - sham	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.

Primary Outcome Measures

Name	Time	Method
Change in the CRS-R total score	4 weeks	Improvement of the CRS-R total score after the end of the anodal session.

Trial Locations

Locations (1)

University of Liege; 🇧🇪 Liege, Belgium