UnknownNot Applicable

tDCS in Acute Stroke Patients

France50 participantsStarted 2017-01-26

Plain-language summary

Very early after the onset of the focal perfusion deficit, excitotoxic mechanisms can lethally damage neurons and glia. Excitotoxicity triggers a number of events that can further contribute to tissue death. Such events include peri-infarct depolarizations (PID) and cortical spreading depolarization (CSD) within the peri-infarct zone or ischaemic penumbra. Noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) are emerging as promising tools, owing to their effects on modulating cortical activity. Experimental studies have indicated that cathodic polarization of the cortical surface blocks initiation of CSD. Moreover, it has been recently demonstrated in murine stroke models that cathodal tDCS exerts a measurable neuroprotective effect in the acute phase of stroke, decreasing the number of spreading depolarizations and reducing the infarct volume by 20 to 30%. The investigators propose here a pilot study, in acute middle cerebral artery stroke patients, with a double blind randomization: cathodal tDCS versus sham tDCS. The duration of this study will be two years. Fifty acute middle cerebral artery stroke patients will be included. The tDCS will begin within 4.5 hours of symptom onset. The main criteria of evaluation will be the extent of diffusion-weighted imaging (DWI) infarct volume between imaging on admission and 24 hours later. The investigators propose the hypothesis that in acute stroke patients, cathodal tDCS could be an adjuvant approach to recanalizing therapies.

Who can participate

Age range

18 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 ≥ 18 years * middle cerebral artery stroke confirmed by MRI * neuroradiology: initial MRI with diffusion and perfusion sequences * NIHSS scale between 4 and 25 * delay since the beginning of symptoms \< 4h30 * intravenous thrombolysis treatment * obtained consent * patient affiliated or benefiting from the French national insurance Exclusion Criteria: * pregnant woman * contraindications for an MRI scan : heart pace-maker, patients who have a metallic foreign body (metal sliver) in their eye or in their brain. * contraindications for the tDCS : scalp or forehead cutaneous lesion, history of intra-cranial surgery * coma * beginning of the symptoms cannot be precisely specified

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

Brain MRI diffusion weighted images

Timeframe: Day 1

Trial details

NCT IDNCT02806856

SponsorCentre Hospitalier St Anne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10

Contact for this trial

Martine GAVARET, MD, PhD

00 33 6 08 21 04 22 martine.gavaret@parisdescartes.fr

View on ClinicalTrials.gov More Acute Stroke trials