Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain (NCT07202455) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
France60 participantsStarted 2026-01-01
Plain-language summary
This is a prospective clinical study to evaluate the efficacy of tDCS stimulation, coupled with conventional rehabilitation, on the development of post-stroke neuropathic pain.
The study involves a double-blind, randomized, sham-controlled experimental protocol involving 2 parallel groups with patients allocated according to a Fleming design (40 patients in the active group, 20 patients in the control group).
The study is aimed at sub-acute post-stroke patients. After recruitment, they will receive 10 sessions of tDCS stimulation (2mA, 20 minutes with a current on/off ramp of 0.1 mA/s). For the control group, stimulation will stop after the current ramp.
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
* Ischemic or hemorrhagic stroke confirmed by MRI or scanner
* Lesion(s) in somato-sensory areas (i.e. mainly in: the pons, thalamus, internal capsule, basal ganglia and operculo-insular regions)
* Sensory and/or motor deficit requiring rehabilitation
* Subacute stage (7 to 45 days post-stroke)
* No neurological deficit or chronic neuropathic pain prior to stroke
* No neuropathic pain at inclusion
* Patient can be followed throughout the study.
* Information letter read and understood
* Able to give informed consent to participate in research
* Affiliation with a social security scheme
Exclusion Criteria:
* Contraindication to tDCS (epilepsy/history of epilepsy, intracranial ferromagnetic material or implanted stimulator, acute eczema or irritated skin over the stimulation area)
* Contraindication to MRI (use of a pacemaker or insulin pump, wearing of a metal prosthesis, intracerebral clip or piercing, claustrophobia)
* Cognitive or language difficulties preventing comprehension of instructions and/or correct clinical assessment
* Patients participating in another research protocol involving a drug in the 30 days prior to inclusion
* Drug or psychoactive substance abuse
* Pregnant or breast-feeding women
* Patients under guardianship or curatorship, deprived of liberty, safeguard of justice
* Major depression
* Patients with Parkinson's disease
* The presence of pre-existing lesions \>1.5 cm (maximum diameter) in a cerebral area belongin…
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.