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Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness (rtDCS in DOC)

Primary Purpose

Disorders of Consciousness, Severe Brain Injury, Post-comatose Non-communicative Patients

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 Disorders of Consciousness

Eligibility Criteria

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

Inclusion Criteria:

  • be in an minimally conscious state
  • be chronic (more then 3 months post insult)
  • stable condition

Exclusion Criteria:

  • NMDA receptor inhibitor drugs
  • modification of the treatment during the protocol
  • illness or infection during the protocol
  • pacemaker
  • metallic cerebral implant
  • prior neurological disorder
  • tDCS or other non-invasive brain stimulation treatment less than 3months before the inclusion in the present study

Sites / Locations

  • University Hospital of Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

anodal stimulation

sham stimulation

Arm Description

Patients receive an anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes). A CRS-R is performed at baseline (before the first stimulation) and after the tDCS session. A final CRS-R is performed 8 week after the end of the session to assess the potential long term effects of tDCS.

Patients receive a sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 5 secondes at the begining and the end of the stimulation to mimic the effects of tDCS). A CRS-R is performed at baseline (before the first stimulation) and after the tDCS session. A final CRS-R is performed 8 week after the end of the session to assess the potential long term effects of tDCS.

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 8 weeks later but no change for the sham session.
Safety of the device (adverse effect)
a questionnaire will be asked to the caregivers and family of the patient to know any adverse effect (drowsiness, redness of the skin, epileptic sizure, sign of pain or discomfort).
Usability of the device in daily clinical practice (compliance of the device by the caregivers)
The tDCS device records the number of stimulations performed during the protocol. We will be able to evaluate the compliance of the device by the caregivers to know if they use it properly and as expected.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2015
Last Updated
March 29, 2017
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT02394691
Brief Title
Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
Acronym
rtDCS in DOC
Official Title
Effect of Daily Left Prefrontal Dorsolateral Transcranial Direct Current Stimulation Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
March 2017 (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

5. Study Description

Brief Summary
In this study, researchers will show to caregivers of patients how to use a tDCS device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). They will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (MCS). 2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. Before and after each session, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tDCS.
Detailed Description
A single session of tDCS showed positive effects on patients in MCS (study published in Neurology, 2014). Nevertheless, the effects went down after 1 or 2 hours. In a second study (Protocol ID: 2009/201/B) we have found that 5 days of tDCS increase the lasting of the effects up to one week. To know if tDCS could be use in clinical daily practice, a new study will evaluate the effects of 20 minutes of tDCS over the left prefrontal dorsolateral cortex for 4 weeks, 5 days per week, in chronic patients in MCS. 2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed, one session will be real (anodal stimulation) and one placebo (sham stimulation). Firstly, the patient will be seen at the hospital for a behavioral assessment (CRS-R) with one of his/her caregiver. The investigator will explain to the caregiver how to perform the stimulation. In addition, he/she will receive a folder and a video. The caregiver will take an exam to be sure he/she performs the tDCS properly. Before and after each stimulation session, behavioral improvement will be assessed with the CRS-R by a trained neuropsychologist, at the hospital. A final assessment will be done 8 weeks after the end of the session to assess the long term effect of tDCS. The compliance will be recorded by the deice to be sure that the caregiver performs the stimulation every day as expected. Researchers expect to see (a) an improvement of the CRS-R total score at the end of the anodal session and (b) this improvement persists for 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorders of Consciousness, Severe Brain Injury, Post-comatose Non-communicative Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal stimulation
Arm Type
Active Comparator
Arm Description
Patients receive an anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes). A CRS-R is performed at baseline (before the first stimulation) and after the tDCS session. A final CRS-R is performed 8 week after the end of the session to assess the potential long term effects of tDCS.
Arm Title
sham stimulation
Arm Type
Placebo Comparator
Arm Description
Patients receive a sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 5 secondes at the begining and the end of the stimulation to mimic the effects of tDCS). A CRS-R is performed at baseline (before the first stimulation) and after the tDCS session. A final CRS-R is performed 8 week after the end of the session to assess the potential long term effects of tDCS.
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 8 weeks later but no change for the sham session.
Time Frame
after each stimulation sessions (4 weeks) and 8 weeks later
Title
Safety of the device (adverse effect)
Description
a questionnaire will be asked to the caregivers and family of the patient to know any adverse effect (drowsiness, redness of the skin, epileptic sizure, sign of pain or discomfort).
Time Frame
Recorded after each stimulations sessions (4 weeks) and 8 weeks later
Title
Usability of the device in daily clinical practice (compliance of the device by the caregivers)
Description
The tDCS device records the number of stimulations performed during the protocol. We will be able to evaluate the compliance of the device by the caregivers to know if they use it properly and as expected.
Time Frame
After the end of the protocol (24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be in an minimally conscious state be chronic (more then 3 months post insult) stable condition Exclusion Criteria: NMDA receptor inhibitor drugs modification of the treatment during the protocol illness or infection during the protocol pacemaker metallic cerebral implant prior neurological disorder tDCS or other non-invasive brain stimulation treatment less than 3months before the inclusion in the present study
Facility Information:
Facility Name
University Hospital of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
24574549
Citation
Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.
Results Reference
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Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness

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