tDCS in MCS: Repeated Stimulations (tDCS in MCS)

• ClinicalTrials.gov Identifier: NCT02019615
• Recruitment Status: Completed
• First Posted: December 24, 2013
• Last Update Posted: March 31, 2017
• Sponsor: University of Liege
• Information provided by (Responsible Party): Aurore Thibaut, University of Liege

Tracking Information

• First Submitted Date: December 18, 2013
• First Posted Date: December 24, 2013
• Last Update Posted Date: March 31, 2017
• Study Start Date: February 2013
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2013)

Change in the CRS-R total score [ Time Frame: after each stimulation and one week later for anodal and sham sessions (total: 1 month) ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 18, 2013)

Influence of the time since insult [ Time Frame: one month ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: tDCS in MCS: Repeated Stimulations
• Official Title: Repeated tDCS in Chronic Minimally Conscious State Patients : a Sham-controlled Randomized Double Blind Study

Brief Summary

In this study researchers 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.

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, a new study will evaluate the effects of tDCS on the left prefrontal dorsolateral cortex for 5 consecutive days in chronic patients in MCS.

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

Researchers 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)

Intervention

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

Study Arms

• 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.
  Intervention: Device: transcranial direct current stimulation
• 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.
  Intervention: Device: transcranial direct current stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 18, 2013): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility 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., dextromethorphan)

Exclusion Criteria:

• premorbid 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT02019615
• Other Study ID Numbers: 2009/201/B
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Aurore Thibaut, University of Liege
• Study Sponsor: University of Liege
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Liege
• Verification Date: March 2017