ClinicalTrials.gov
ClinicalTrials.gov Menu

Closed-loop tDCS in Patients in Minimally Conscious State

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03810079
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Aurore Thibaut, University Hospital of Liege

Brief Summary:

This research will test a closed-loop system using EEG-arousal measures (spectral entropy) to define the best moment of the day for application of transcranial direct current stimulation (tDCS) in patients in MCS

This study aims at answering the following questions:

  1. Is tDCS applied during high vigilance states more effective in increasing the level of conscious awareness than low vigilance states and/or sham stimulation in patients in minimally conscious state (MCS)?
  2. Is the EEG pattern (connectivity, complexity) different after application of active or sham tDCS at high vigilance or low vigilance states?
  3. Is there a difference in the profile of tDCS-responders as compared to non-responders with regards to etiology, clinical diagnosis (MCS+/MCS-), age, gender, time post-injury, functional outcome, structural and functional neuroimaging findings and EEG markers?

Condition or disease Intervention/treatment Phase
Minimally Conscious State Device: Anodal transcranial direct current stimulation Device: Sham transcranial direct current stimulation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized double-blind sham-controlled crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Closed-loop Application of tDCS to Promote Responsiveness of Patients in MCS
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Active Comparator: Anodal tDCS High Vigilance
Patients will undergo continuous 8 channels EEG and receive anodal tDCS (bilateral prefrontal stimulation) at a pre-determined high level of EEG-derived spectral entropy during 20 minutes followed by a clinical assessment (Coma Recovery Scale-Revised)
Device: Anodal transcranial direct current stimulation
Neuromodulation of bilateral prefrontal areas using 2 mA tDCS delivered during 20 minutes via sponge electrodes on the scalp
Other Name: Anodal tDCS

Active Comparator: Anodal tDCS Low Vigilance
Patients will undergo continuous 8 channels EEG and receive anodal tDCS (bilateral prefrontal stimulation) at a pre-determined low level of EEG-derived spectral entropy during 20 minutes followed by a clinical assessment (Coma Recovery Scale-Revised)
Device: Anodal transcranial direct current stimulation
Neuromodulation of bilateral prefrontal areas using 2 mA tDCS delivered during 20 minutes via sponge electrodes on the scalp
Other Name: Anodal tDCS

Sham Comparator: Sham tDCS Random Vigilance
Patients will undergo continuous 8 channels EEG and receive sham tDCS (bilateral prefrontal stimulation) at a random level of EEG-derived spectral entropy during 20 minutes followed by a clinical assessment (Coma Recovery Scale-Revised)
Device: Sham transcranial direct current stimulation
Identical to anodal tDCS, except that the stimulation is stopped after 15 seconds.
Other Name: Sham tDCS




Primary Outcome Measures :
  1. Change in EEG [ Time Frame: It will be measured throughout the 6 hour session and reported over the course of about 3 weeks ]
    8 channels EEG will be continuously recorded to identify potential cortical changes induced by the stimulation.


Secondary Outcome Measures :
  1. Change in the CRS-R total score [ Time Frame: It will be measured at the beginning of the 6 hour session for 30 minutes, at the end of the 6 hour session for 30 minutes and reported over the course of about 3 days ]
    Coma Recovery Scale-Revised (CRS-R- will be performed before and after tDCS (anodal and sham).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CNS medication stable for at least a week,
  • Stable diagnosis of MCS (no diagnosis change based on 2 CRS-R performed within 1 week).
  • Adult (16 years old - 65 years old)
  • 3 months post injury

Exclusion Criteria:

  • open craniotomies,
  • VPS under the stimulated area (prefrontal cortex),
  • pacemaker,
  • metallic cerebral implant, according to safety criteria for transcranial electric stimulation,
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810079


Locations
Belgium
University Hospital of Liege
Liege, Belgium, 4000
Sponsors and Collaborators
University Hospital of Liege

Responsible Party: Aurore Thibaut, PhD, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT03810079     History of Changes
Other Study ID Numbers: 2015/251
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aurore Thibaut, University Hospital of Liege:
transcranial direct current stimulation
minimally conscious state
disorders of consciousness
non invasive brain stimulation
neuromodulation

Additional relevant MeSH terms:
Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms