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tDCS in MCS: Repeated Stimulations (tDCS in MCS)

Primary Purpose

Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke) focused on measuring disorders of consciousness, minimally conscious state, traumatic brain injury, stroke, transcranial direct current stimulation

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

anodal stimulation

sham stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the CRS-R total score
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
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.

Full Information

First Posted
December 18, 2013
Last Updated
March 29, 2017
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT02019615
Brief Title
tDCS in MCS: Repeated Stimulations
Acronym
tDCS in MCS
Official Title
Repeated tDCS in Chronic Minimally Conscious State Patients : a Sham-controlled Randomized Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)
Keywords
disorders of consciousness, minimally conscious state, traumatic brain injury, stroke, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the CRS-R total score
Description
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.
Time Frame
after each stimulation and one week later for anodal and sham sessions (total: 1 month)
Secondary Outcome Measure Information:
Title
Influence of the time since insult
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

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tDCS in MCS: Repeated Stimulations

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