CompletedNot Applicable

Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session

France66 participantsStarted 2015-10

Plain-language summary

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients. However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients. In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.

Who can participate

Age range

18 Years – 80 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: * Age between 18 and 80 years * Disorder of consciousness assessed by CRS-R (VS, MCS, exitMCS) * Patients with stable clinical examination (even in intensive care unit) * Structural brain injury confirmed by cerebral imaging (MRI or TDM) Exclusion Criteria: * Refractory status epilepticus * Known preexisting severe neurodegenerative disease (ie: Alzheimer disease, Lewy body dementia, ...) * MRI contraindication: metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis * Pregnant, parturient or breastfeeding women

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

Support vector machine multivariate prediction of consciousness from resting state EEG markers

Timeframe: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)

Evoked response potential during auditory oddball paradigm

Timeframe: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)

Trial details

NCT IDNCT04035655

SponsorGroupe Hospitalier Pitie-Salpetriere

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

View on ClinicalTrials.gov More Disorder of Consciousness trials

Plain-language summary

Who can participate

Age range

18 Years – 80 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.

What they're measuring

Support vector machine multivariate prediction of consciousness from resting state EEG markers

Timeframe: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)

Evoked response potential during auditory oddball paradigm

Timeframe: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)