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Completed

NCT Number: NCT02394691

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

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.

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Key information

Conditions

Disorders of Consciousness Brain Diseases Brain Injuries Central Nervous System Diseases Consciousness Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Post-comatose Non-communicative Patients Severe Brain Injury Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Liège

Liège, 4000, Belgium

About this study

A single session of tDCS showed positive effects on patients in MCS (study published in Neurology, 2014). Nevertheless, the effects went down after 1 or 2 hours. In a second study (Protocol ID: 2009/201/B) we have found that 5 days of tDCS increase the lasting of the effects up to one week.

To know if tDCS could be use in clinical daily practice, a new study will evaluate the effects of 20 minutes of tDCS over the left prefrontal dorsolateral cortex for 4 weeks, 5 days per week, in chronic patients in MCS.

2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed, one session will be real (anodal stimulation) and one placebo (sham stimulation).

Firstly, the patient will be seen at the hospital for a behavioral assessment (CRS-R) with one of his/her caregiver. The investigator will explain to the caregiver how to perform the stimulation. In addition, he/she will receive a folder and a video. The caregiver will take an exam to be sure he/she performs the tDCS properly.

Before and after each stimulation session, behavioral improvement will be assessed with the CRS-R by a trained neuropsychologist, at the hospital. A final assessment will be done 8 weeks after the end of the session to assess the long term effect of tDCS.

The compliance will be recorded by the deice to be sure that the caregiver performs the stimulation every day as expected.

Researchers expect to see (a) an improvement of the CRS-R total score at the end of the anodal session and (b) this improvement persists for 8 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • NMDA receptor inhibitor drugs
  • modification of the treatment during the protocol
  • illness or infection during the protocol
  • pacemaker
  • metallic cerebral implant
  • prior neurological disorder
  • tDCS or other non-invasive brain stimulation treatment less than 3months before the inclusion in the present study

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 sessions (4 weeks) and 8 weeks later

    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.

  2. Safety of the device (adverse effect)

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

    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).

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

    Time frame: After the end of the protocol (24 weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Effect of Daily Left Prefrontal Dorsolateral Transcranial Direct Current Stimulation Sessions on Cognitive Improvement in Patients With Disorders of Consciousness

Acronym: rtDCS in DOC

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 20, 2015
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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