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Long-term Effect of tDCS in Patients With Disorders of Consciousness

Primary Purpose

Disorder of Consciousness

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

About this trial

This is an interventional treatment trial for Disorder of Consciousness

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CNS medication stable for at least a week
  • Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week).
  • Between 3 and 24 months post injury
  • Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)

Exclusion Criteria:

  • Craniotomies encompassing the frontal region (electrodes location)
  • VPS under the stimulated area (prefrontal cortex)
  • Pacemaker
  • Metallic cerebral implant
  • Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).

Sites / Locations

  • University of Liege

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

anodal stimulation

sham stimulation

Arm Description

Patients will receive anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.

Patients will receive sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2017
Last Updated
November 2, 2022
Sponsor
University of Liege
Collaborators
Fondazione Salvatore Maugeri, Italy, Université Catholique de Louvain, Belgium, Hospitales Nisa, Spain, I.R.C.C.S. Fondazione Santa Lucia, Italy, Schoen Clinic Bad Aibling, Germany, Research Center of Neurology, Russia, Therapiezentrum Burgau, Germany, pavlov state medical university, Russia, Azienda Unita Sanitaria Locale di Piacenza, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03114397
Brief Title
Long-term Effect of tDCS in Patients With Disorders of Consciousness
Official Title
Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Fondazione Salvatore Maugeri, Italy, Université Catholique de Louvain, Belgium, Hospitales Nisa, Spain, I.R.C.C.S. Fondazione Santa Lucia, Italy, Schoen Clinic Bad Aibling, Germany, Research Center of Neurology, Russia, Therapiezentrum Burgau, Germany, pavlov state medical university, Russia, Azienda Unita Sanitaria Locale di Piacenza, Italy

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 multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected. This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal stimulation
Arm Type
Active Comparator
Arm Description
Patients will receive anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.
Arm Title
sham stimulation
Arm Type
Placebo Comparator
Arm Description
Patients will receive sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation - active
Intervention Description
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation - sham
Intervention Description
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CNS medication stable for at least a week Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week). Between 3 and 24 months post injury Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC) Exclusion Criteria: Craniotomies encompassing the frontal region (electrodes location) VPS under the stimulated area (prefrontal cortex) Pacemaker Metallic cerebral implant Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).
Facility Information:
Facility Name
University of Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
28281845
Citation
Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10.
Results Reference
background
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
background

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Long-term Effect of tDCS in Patients With Disorders of Consciousness

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