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Completed

NCT Number: NCT02019615

tDCS in MCS: Repeated Stimulations

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.

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Key information

Conditions

Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke) Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Craniocerebral Trauma Hypoxia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Signs and Symptoms, Respiratory Stroke Trauma, Nervous System Unconsciousness Vascular Diseases Wounds and Injuries

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Liège

Liège, 4000, Belgium

About this study

Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the left prefrontal dorsolateral cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). 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.

Researchers expected to see an improvement of the CRS-r total score at the end of the anodal session and that this improvement persists for a week.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

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

Primary outcomes

  1. Change in the CRS-R total score

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

    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.

Secondary outcomes

  1. Influence of the time since insult

    Time frame: one month

    Influence of the time since insult of the results. We expected that the longer a patient is in MCS, the lower is his/her improvement after the tDCS session.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Repeated tDCS in Chronic Minimally Conscious State Patients : a Sham-controlled Randomized Double Blind Study

Acronym: tDCS in MCS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2013
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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