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Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes

Primary Purpose

Vegetative State, Minimally Conscious State, Disorder of Consciousness

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
anodal tDCS
sham tDCS
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vegetative State focused on measuring Vegetative state, Minimally Conscious State, Disorders of consciousness, Transcranial direct current stimulation, Non invasive brain stimulation, Neuromodulation, High density electroencephalography

Eligibility Criteria

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

Inclusion Criteria:

  • post-comatose patients
  • patients in vegetative state/unresponsive wakefulness syndrome or 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
  • patients < 28 days after the acute brain injury
  • patients with a metallic cerebral implant/a shunt
  • cranioplasty

Sites / Locations

  • University Hospital of Liege

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

anodal tDCS

sham tDCS

Arm Description

Patients will receive anodal tDCS (left dorsolateral prefrontal stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (256 channels EEG).

Patients will receive sham tDCS (15 secondes of stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (256 channels EEG).

Outcomes

Primary Outcome Measures

Change in the CRS-R scores
CRS-R will be performed before and after tDCS (anodal and sham). Comparison of the treatment effect (CRS-R total score after tDCS minus before) between real and sham tDCS

Secondary Outcome Measures

Change in EEG
256 channels EEG will be record before and after tDCS to record potential cortical changes induce by the stimulation.
Change in the vigilance level
Ocular parameters will be record using glasses before and after tDCS to record potential change of the vigilance level

Full Information

First Posted
January 29, 2019
Last Updated
July 16, 2019
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT03823508
Brief Title
Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes
Official Title
Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (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
Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood. Here we aim to assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC.
Detailed Description
Currently, therapeutic options for severely brain-injured patients with disorders of consciousness (DOC), including patients in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS), are limited and still need to be improved to influence long-term outcomes. Non-invasive brain stimulations (NIBS) techniques have recently shown promising results in DOC. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood.In the present protocol, the investigators will assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC in a double-blind sham-controlled design. One anodal and one sham tDCS will be delivered in a randomized order in chronic (>28 days post-onset) severely brain-damaged patients. The stimulation will have an intensity of 2 mA and will last 20 minutes. The anode will be placed on the left dorsolateral prefrontal cortex and the cathode on the right supraorbital region. Ten minutes of high-density EEG will be recorded using a 256-channel saline electrode net (Electrical Geodesics) directly before and after each tDCS session. Behavioral assessments will be performed using the Coma Recovery Scale-Revised before and after each session by an investigator blinded to the treatment allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vegetative State, Minimally Conscious State, Disorder of Consciousness
Keywords
Vegetative state, Minimally Conscious State, Disorders of consciousness, Transcranial direct current stimulation, Non invasive brain stimulation, Neuromodulation, High density electroencephalography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS
Arm Type
Active Comparator
Arm Description
Patients will receive anodal tDCS (left dorsolateral prefrontal stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (256 channels EEG).
Arm Title
sham tDCS
Arm Type
Placebo Comparator
Arm Description
Patients will receive sham tDCS (15 secondes of stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (256 channels EEG).
Intervention Type
Device
Intervention Name(s)
anodal tDCS
Intervention Description
Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and a high density EEG. The anode will be placed over F3 in order to stimulate the left dorsolateral prefrontal cortex and the cathode over the right supraorbital area.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.
Primary Outcome Measure Information:
Title
Change in the CRS-R scores
Description
CRS-R will be performed before and after tDCS (anodal and sham). Comparison of the treatment effect (CRS-R total score after tDCS minus before) between real and sham tDCS
Time Frame
Baseline and directly after the tDCS (20 minutes)
Secondary Outcome Measure Information:
Title
Change in EEG
Description
256 channels EEG will be record before and after tDCS to record potential cortical changes induce by the stimulation.
Time Frame
Baseline and directly after the tDCS (20 minutes)
Title
Change in the vigilance level
Description
Ocular parameters will be record using glasses before and after tDCS to record potential change of the vigilance level
Time Frame
Baseline and directly after the tDCS (20 minutes)

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: post-comatose patients patients in vegetative state/unresponsive wakefulness syndrome or 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 patients < 28 days after the acute brain injury patients with a metallic cerebral implant/a shunt cranioplasty
Facility Information:
Facility Name
University Hospital of Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

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Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes

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