Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Effect of tDCS in Patients With Disorders of Consciousness

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: NCT03114397
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Fondazione Salvatore Maugeri, Italy
Université Catholique de Louvain, Belgium
Hospitales Nisa, Spain
I.R.C.C.S. Fondazione Santa Lucia, Italy
Schoen Clinic Bad Aibling, Germany
Research Center of Neurology, Russia
Therapiezentrum Burgau, Germany
pavlov state medical university, Russia
Azienda Unita Sanitaria Locale di Piacenza, Italy
Information provided by (Responsible Party):
Aurore Thibaut, University of Liege

Brief Summary:

In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected.

This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.


Condition or disease Intervention/treatment Phase
Disorder of Consciousness Device: transcranial direct current stimulation - active Device: transcranial direct current stimulation - sham Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Active Comparator: anodal stimulation
Patients will receive anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.
Device: transcranial direct current stimulation - active
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.

Placebo Comparator: sham stimulation
Patients will receive sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.
Device: transcranial direct current stimulation - sham
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.




Primary Outcome Measures :
  1. Change in the CRS-R total score [ Time Frame: 4 weeks ]
    Improvement of the CRS-R total score after the end of the anodal session.



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.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 80 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 (no diagnosis change based on 2 CRS-R performed within 1 week).
  • Between 3 and 24 months post injury
  • Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)

Exclusion Criteria:

  • Craniotomies encompassing the frontal region (electrodes location)
  • VPS under the stimulated area (prefrontal cortex)
  • Pacemaker
  • Metallic cerebral implant
  • 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): NCT03114397


Contacts
Layout table for location contacts
Contact: Aurore Thibaut, PhD +32 4 366 24 44 athibaut@ulg.ac.be

Locations
Layout table for location information
Belgium
University of Liege Recruiting
Liege, Belgium, 4000
Contact: Aurore Thibaut, PhD    003243668069    athibaut@ulg.ac.be   
Contact: Geraldine Martens, MSc    00323668070    geraldine.martens@ulg.ac.be   
Sponsors and Collaborators
University of Liege
Fondazione Salvatore Maugeri, Italy
Université Catholique de Louvain, Belgium
Hospitales Nisa, Spain
I.R.C.C.S. Fondazione Santa Lucia, Italy
Schoen Clinic Bad Aibling, Germany
Research Center of Neurology, Russia
Therapiezentrum Burgau, Germany
pavlov state medical university, Russia
Azienda Unita Sanitaria Locale di Piacenza, Italy
Publications:
Layout table for additonal information
Responsible Party: Aurore Thibaut, Principal Investigator, University of Liege
ClinicalTrials.gov Identifier: NCT03114397    
Other Study ID Numbers: 2014/113b
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders