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

NCT03114397 | Completed

• 1 other identifier: 2014/113b
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Outcome Measures

Primary Outcomes (1)

• Change in the CRS-R total score

  Improvement of the CRS-R total score after the end of the anodal session.

  4 weeks

Study Arms (2)

anodal stimulation

ACTIVE COMPARATOR

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.

Device: transcranial direct current stimulation - active

sham stimulation

PLACEBO COMPARATOR

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.

Device: transcranial direct current stimulation - sham

Interventions

transcranial direct current stimulation - active DEVICE

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

anodal stimulation

transcranial direct current stimulation - sham 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.

sham stimulation

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Liege: lead
• Fondazione Salvatore Maugeri, Italy: collaborator
• Université Catholique de Louvain, Belgium: collaborator
• Hospitales Nisa, Spain: collaborator
• I.R.C.C.S. Fondazione Santa Lucia, Italy: collaborator
• Schoen Clinic Bad Aibling, Germany: collaborator
• Research Center of Neurology, Russia: collaborator
• Therapiezentrum Burgau, Germany: collaborator
• pavlov state medical university, Russia: collaborator
• Azienda Unita Sanitaria Locale di Piacenza, Italy: collaborator

Study Sites (1)

University of Liege

Liège, 4000, Belgium

Location

Related Publications (2)

• Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10.

  PMID: 28281845 BACKGROUND

• Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.

  PMID: 24574549 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 14, 2017
• Study Start: September 1, 2017
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

BE (1)