NCT02626403

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

November 30, 2015

Last Update Submit

January 29, 2019

Conditions

Vegetative StateMinimally Conscious StateDisorders of Consciousness

Keywords

vegetative stateminimally conscious statedisorder of consciousnesstranscranial current direct stimulationnon invasive brain stimulationneuromodulation

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and directly after the tDCS (20 minutes)

Secondary Outcomes (2)

  • Change in EEG

    Baseline and directly after the tDCS (20 minutes)

  • Change in CRS-R subscores

    Baseline and directly after the tDCS (20 minutes)

Study Arms (2)

anodal tDCS

ACTIVE COMPARATOR

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).

Device: Anodal tDCS

sham tDCS

SHAM COMPARATOR

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).

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 an EEG. The anodes will be placed over F3, F4, CP5, and CP6 in order to stimulation the fronto-parietal cortex bilaterally.

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 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
  • cranioplasty
  • shunt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liege

Liège, 4000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 24574549RESULT

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
PhD

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 10, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2017

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

BE(1)