tDCS in MCS: Repeated Stimulations

NCT02019615 | Completed DMC

• 1 other identifier: 2009/201/B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS). 2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.

Conditions

Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)

Keywords

disorders of consciousness; minimally conscious state; traumatic brain injury; stroke; transcranial direct current stimulation

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 and one week later but no change for the sham session.

  after each stimulation and one week later for anodal and sham sessions (total: 1 month)

Secondary Outcomes (1)

• Influence of the time since insult

  one month

Study Arms (2)

anodal stimulation

ACTIVE COMPARATOR

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

Device: transcranial direct current stimulation

sham stimulation

SHAM COMPARATOR

Patients received sham tDCS (5 secondes of stimulation) every day for 5 days. A CRS-R is performed at baseline (before the first stimulation) and after each tDCS. A final CRS-R is performed one week after the end of the session.

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

You may qualify if:

• post comatose patients
• patients in minimally conscious state
• patients with stable condition
• patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

You may not qualify if:

• premorbid neurology antecedent
• patients in coma or vegetative state
• patients \< 3 months after the acute brain injury
• patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University of Liège

Liège, Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Hypoxia; Brain Injuries, Traumatic; Stroke; Consciousness Disorders; Persistent Vegetative State

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Unconsciousness

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

BE (1)