Trial record 3 of 8 for:    Open Studies | "Persistent Vegetative State"

tDCS in MCS: Repeated Stimulations

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospital of Liege
Sponsor:
Collaborators:
James S McDonnell Foundation
Belgian National Fund for Scientific Research (FNRS)
Concerted Research Action
Public Utility Foundation - Université Européenne du Travail
Information provided by (Responsible Party):
Aurore Thibaut, University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT02019615
First received: December 18, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

In this study we 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.


Condition Intervention Phase
Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)
Device: transcranial direct current stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repeated tDCS in Chronic Minimally Conscious State Patients : a Sham-controlled Randomized Double Blind Study

Resource links provided by NLM:


Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:
  • Change in the CRS-R total score [ Time Frame: after each stimulation and one week later for anodal and sham sessions (total: 1 month) ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Influence of the time since insult [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: anodal stimulation
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
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
Sham Comparator: sham stimulation
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
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

Detailed Description:

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, we will start a study where we will apply tDCS on the left prefrontal dorsolatral cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one sessin 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.

We 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.

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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., dextromethrophan)

Exclusion Criteria:

  • premorbit 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019615

Contacts
Contact: Aurore Thibaut, MSc 003243662362 athibaut@ulg.ac.be
Contact: Steven Laureys, MD, PhD 003243662304 steven.laureys@ulg.ac.be

Locations
Belgium
University of Liège Recruiting
Liège, Belgium, 4000
Contact: Annick Claes, PhD    003243662316    annick.claes@ulg.ac.be   
Sponsors and Collaborators
University Hospital of Liege
James S McDonnell Foundation
Belgian National Fund for Scientific Research (FNRS)
Concerted Research Action
Public Utility Foundation - Université Européenne du Travail
  More Information

Additional Information:
No publications provided

Responsible Party: Aurore Thibaut, MSc, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT02019615     History of Changes
Other Study ID Numbers: 2009/201/B
Study First Received: December 18, 2013
Last Updated: December 18, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital of Liege:
disoders of consciousness
minimally conscious state
traumatic brain injury
stroke
transcranial direct current stimulation

Additional relevant MeSH terms:
Persistent Vegetative State
Anoxia
Stroke
Brain Injuries
Wounds and Injuries
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 27, 2014