RecruitingNot ApplicableNCT03810079

Closed-loop tDCS in Patients in Minimally Conscious State

Closed-loop Application of tDCS to Promote Responsiveness of Patients in MCS

Sponsor

University of Liege

Enrollment

16 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

Minimally Conscious State

Summary

This research will test a closed-loop system using EEG-arousal measures (spectral entropy) to define the best moment of the day for application of transcranial direct current stimulation (tDCS) in patients in MCS This study aims at answering the following questions: 1. Is tDCS applied during high vigilance states more effective in increasing the level of conscious awareness than low vigilance states in patients in minimally conscious state (MCS)? 2. Is the EEG pattern (connectivity, complexity) different after application of active or sham tDCS at high vigilance or low vigilance states? 3. Is there a difference in the profile of tDCS-responders as compared to non-responders with regards to etiology, clinical diagnosis (MCS+/MCS-), age, gender, time post-injury, functional outcome, structural and functional neuroimaging findings and EEG markers?

Eligibility

Min Age: 16 YearsMax Age: 75 Years

Inclusion Criteria4

CNS medication stable for at least a week,
Stable diagnosis of MCS (no diagnosis change based on 2 CRS-R performed within 1 week).
Adult (16 years old - 75 years old)
\> 28 days post injury

Exclusion Criteria5

open craniotomies,
VPS under the stimulated area (prefrontal cortex),
pacemaker,
metallic cerebral implant, according to safety criteria for transcranial electric stimulation,
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).

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