Closed-loop tDCS in Patients in Minimally Conscious State (NCT03810079) | Clinical Trial Compass
CompletedNot Applicable
Closed-loop tDCS in Patients in Minimally Conscious State
Belgium16 participantsStarted 2019-08-01
Plain-language 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?
Who can participate
Age range
16 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in EEG
Timeframe: It will be measured throughout the 6 hour session and reported over the course of about 3 weeks