Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness

NCT02394691 | Completed

• 1 other identifier: 2014/113
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, researchers will show to caregivers of patients how to use a tDCS device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). They will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (MCS). 2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. Before and after each session, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tDCS.

Conditions

Disorders of Consciousness; Severe Brain Injury; Post-comatose Non-communicative Patients

Outcome Measures

Primary Outcomes (3)

• Change in the CRS-R total score

  Improvement of the CRS-R total score after the end of the anodal session and 8 weeks later but no change for the sham session.

  after each stimulation sessions (4 weeks) and 8 weeks later

• Safety of the device (adverse effect)

  a questionnaire will be asked to the caregivers and family of the patient to know any adverse effect (drowsiness, redness of the skin, epileptic sizure, sign of pain or discomfort).

  Recorded after each stimulations sessions (4 weeks) and 8 weeks later

• Usability of the device in daily clinical practice (compliance of the device by the caregivers)

  The tDCS device records the number of stimulations performed during the protocol. We will be able to evaluate the compliance of the device by the caregivers to know if they use it properly and as expected.

  After the end of the protocol (24 weeks)

Study Arms (2)

anodal stimulation

ACTIVE COMPARATOR

Patients receive an anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes). A CRS-R is performed at baseline (before the first stimulation) and after the tDCS session. A final CRS-R is performed 8 week after the end of the session to assess the potential long term effects of tDCS.

Device: transcranial direct current stimulation

sham stimulation

PLACEBO COMPARATOR

Patients receive a sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 5 secondes at the begining and the end of the stimulation to mimic the effects of tDCS). A CRS-R is performed at baseline (before the first stimulation) and after the tDCS session. A final CRS-R is performed 8 week after the end of the session to assess the potential long term effects of tDCS.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session

anodal stimulation; sham stimulation

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• be in an minimally conscious state
• be chronic (more then 3 months post insult)
• stable condition

You may not qualify if:

• NMDA receptor inhibitor drugs
• modification of the treatment during the protocol
• illness or infection during the protocol
• pacemaker
• metallic cerebral implant
• prior neurological disorder

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liège

Liège, Liège, 4000, Belgium

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

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

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 20, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

BE (1)