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Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness

Primary Purpose

Vegetative State, Minimally Conscious State, Disorders 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, disorder of consciousness, transcranial current direct stimulation, non invasive brain stimulation, neuromodulation

Eligibility Criteria

16 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
  • patients < 28 days after the acute brain injury
  • patients with a metallic cerebral implant
  • cranioplasty
  • shunt

Sites / Locations

  • University of Liege

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

anodal tDCS

sham tDCS

Arm Description

Patients will receive anodal tDCS (bilateral fronto-parietal stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).

Patients will receive sham tDCS (15 second of stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).

Outcomes

Primary Outcome Measures

Change in the CRS-R total score
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
8 channels EEG will be record before and after tDCS to record potential cortical changes induce by the stimulation.
Change in CRS-R subscores
Same analysis as for CRS-R total score but on each of the 6 sub-scales

Full Information

First Posted
November 30, 2015
Last Updated
January 29, 2019
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT02626403
Brief Title
Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness
Official Title
Effect of Fronto-parietal Transcranial Direct Stimulation on the Level of Consciousness in Patients With Disorders of Consciousness
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 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
Previous studies showed that anodal transcranial direct current stimulation (tDCS) transiently improves performance of memory and attention. In severely brain injured patients with disorders of consciousness (DOC), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other brain areas could be stimulated in order to increase the number of responders. In this study, investigators will assess the effects of bilateral fronto-parietal tDCS on Coma Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled experimental design.
Detailed Description
Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC). A previous study showed that a single stimulation (using transcranial direct current stimulation - tDCS) of the left prefrontal cortex induces an behavioral improvement in some patients in DOC. Nevertheless, only 43% of patients in MCS responded to the stimulation. Therefore, it is needed to find new protocols to increase the number of responders and improve the effect of tDCS in patients with DOC. In this study, investigators aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) over right and left fronto-temporal cortices (using 4 anodes and 4 cathodes), on the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3, F3, CP5 and CP6. tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease. By increasing the surface of the stimulated area, it is expected to increase the number of responders as patients' brain lesion are very heterogeneous and widespread.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vegetative State, Minimally Conscious State, Disorders of Consciousness
Keywords
vegetative state, minimally conscious state, disorder of consciousness, transcranial current direct stimulation, non invasive brain stimulation, neuromodulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS
Arm Type
Active Comparator
Arm Description
Patients will receive anodal tDCS (bilateral fronto-parietal stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Patients will receive sham tDCS (15 second of stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (8 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 an EEG. The anodes will be placed over F3, F4, CP5, and CP6 in order to stimulation the fronto-parietal cortex bilaterally.
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 total score
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
8 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 CRS-R subscores
Description
Same analysis as for CRS-R total score but on each of the 6 sub-scales
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 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 cranioplasty shunt
Facility Information:
Facility Name
University of Liege
City
Liege
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
result

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Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness

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