NCT03823508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

January 29, 2019

Last Update Submit

July 16, 2019

Conditions

Vegetative StateMinimally Conscious StateDisorder of Consciousness

Keywords

Vegetative stateMinimally Conscious StateDisorders of consciousnessTranscranial direct current stimulationNon invasive brain stimulationNeuromodulationHigh density electroencephalography

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and directly after the tDCS (20 minutes)

Secondary Outcomes (2)

  • Change in EEG

    Baseline and directly after the tDCS (20 minutes)

  • Change in the vigilance level

    Baseline and directly after the tDCS (20 minutes)

Study Arms (2)

anodal tDCS

ACTIVE COMPARATOR

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).

Device: anodal tDCS

sham tDCS

PLACEBO COMPARATOR

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).

Device: sham tDCS

Interventions

anodal tDCSDEVICE

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.

anodal tDCS
sham tDCSDEVICE

Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.

sham tDCS

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • premorbid neurology antecedent
  • patients in coma
  • patients \< 28 days after the acute brain injury
  • patients with a metallic cerebral implant/a shunt
  • cranioplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liege

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Persistent Vegetative StateConsciousness Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesUnconsciousnessNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 30, 2019

Study Start

January 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations

BE(1)