Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness (tDCS in DOC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aurore Thibaut, University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT01673126
First received: August 14, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a double-blind sham-controlled experimental design.


Condition Intervention Phase
Vegetative State
Minimally Conscious State
Disorders of Consciousness
Device: Anodal tDCS
Device: sham tDCS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Sham-controlled Randomised Double Blind Study

Resource links provided by NLM:


Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:
  • Change in CRS-R Total Scores [ Time Frame: Baseline and directly after the tDCS (20 minutes) ] [ Designated as safety issue: Yes ]

    At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations

    The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.

    Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).

    The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.



Secondary Outcome Measures:
  • Influence of Diagnosis on the Results [ Time Frame: participants will be followed for the duration of 1 year ] [ Designated as safety issue: Yes ]
  • Influence of Etiology on the Results [ Time Frame: participants will be followed for the duration of 1 year ] [ Designated as safety issue: No ]
  • Influence of Time Since Insult on the Results [ Time Frame: participants will be followed for the duration of 1 year ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anodal tDCS
Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)
Device: Anodal tDCS
patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)
Sham Comparator: sham tDCS
Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
Device: sham tDCS
Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.

Detailed Description:

Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC).

Investigator aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPF) on the level of consciousness in DOC patients in a double blind randomized sham controlled study.

tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability at stimulation sites via weak polarizing currents, previously reported to transiently improve working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease.

  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 vegetative/unresponsive or minimally conscious state
  • patients with stable cardiorespiratory parameters
  • patients free of sedative drugs and Na+ or Ca++ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)

Exclusion Criteria:

  • premorbit neurology antecedent
  • patients in coma or <1week after the acute brain insult
  • 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: NCT01673126

Locations
Belgium
University Hospital of Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital of Liege
Investigators
Study Chair: Steven Laureys, MD, PhD Coma Science Group, Cyclotron Research Centre, University and University Hospital of Liège
  More Information

Publications:

Responsible Party: Aurore Thibaut, Principal Investigator, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT01673126     History of Changes
Other Study ID Numbers: 2009/201
Study First Received: August 14, 2012
Results First Received: December 18, 2013
Last Updated: May 12, 2014
Health Authority: Belgium: Ethics Committee
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by University Hospital of Liege:
vegetative state
minimally conscious state
disorders of consciousness
transcranial direct current stimulation

Additional relevant MeSH terms:
Consciousness Disorders
Disease
Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Unconsciousness

ClinicalTrials.gov processed this record on October 23, 2014