UnknownPhase 3

Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients

France300 participantsStarted 2017-01

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 optimal intensity of electrical current stimulation remains unknown. This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.

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: * Non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities) * Patients with stable clinical examination * Age between 18 and 80 years * Brain injury confirmed by cerebral imaging (MRI or TDM) * Disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS) Exclusion Criteria: * Status epilepticus * Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia) * Pregnancy * Patients underage

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

Change of the Coma Recovery Scale-Revised score according to tDCS current intensity (2mA versus 0.2mA)

Timeframe: Last Day of 0.2mA session (Day 14th or Day 28th) versus Last Day of 2mA session (Day 14th or Day 28th)

Change from baseline of the Coma Recovery Scale-Revised score after 2mA tDCS current intensity

Timeframe: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

Change from baseline of the Coma Recovery Scale-Revised score after 0.2mA tDCS current intensity

Timeframe: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)

Trial details

NCT IDNCT03007784

SponsorGroupe Hospitalier Pitie-Salpetriere

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01

Contact for this trial

Jacobo Sitt, MD PhD

+33 1 57 27 43 17 jacobo.sitt@icm-institute.org

View on ClinicalTrials.gov More Disorder of Consciousness trials