Effects of Mepivacaine on Neurological Symptoms After Stroke

Evaluation of the Efficacy and Safety of Mepivacaine on the Neurological Sequelae of Cerebral Infarction

This study is testing if mepivacaine injections can help people who have had a stroke feel better by improving their neurological symptoms like movement issues and vision problems.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT05222828 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of subcutaneous mepivacaine injections on chronic neurological symptoms in patients who have suffered an ischemic stroke. The study is based on a previous observation where a patient regained near-normal vision after receiving mepivacaine, suggesting potential benefits for other stroke-related deficits. Participants will be assessed for specific neurological impairments, including motor deficits, aphasia, and visual scotomas, to evaluate the treatment's efficacy. The trial aims to quantify improvements using reliable assessment scales.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have experienced an ischemic stroke more than 30 days prior and exhibit specific neurological deficits.

Not a fit: Patients with hypersensitivity to local anesthetics, uncontrolled epilepsy, or those with certain severe comorbidities may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with chronic neurological symptoms following a stroke.

How similar studies have performed: While this approach is novel, previous studies have shown promising results with similar interventions in small patient populations.

Eligibility criteria

Inclusion Criteria:

* Ischemic stroke more than 30 days old
* Age between 18 and 85 years old
* At least one deficit among:
* motor deficit: score \< 56 on the Fugl-Meyer scale
* aphasia: score ≥4 on the Aphasia Rapid Test,
* presence of a clinically observable visual scotoma
* Having given their written consent
* Be affiliated with a social security scheme, Universal Medical Coverage (CMU) or any equivalent scheme

Exclusion Criteria:

* Hypersensitivity to amide-bonded local anesthetics.
* Atrioventricular conduction disorders requiring permanent electro-systolic training not yet performed.
* Epilepsy not controlled by treatment.
* Porphyritic subjects.
* Patients with a motor deficit (but no aphasia or scotomas) in whom there is spasticity leading to a major reduction in joint amplitude in passive motion
* Minor patients, under curatorship or guardianship, under legal protection, deprived of liberty, pregnant or breastfeeding women
* Pathologies involving the vital prognosis or compromising follow-up during the study period
* Patient undergoing local amine anesthesia in the 7 days preceding V1.
* Patients currently treated with no anti-arrhythmics such as tocainide, aprindine and mexiletine
* Patients with a contraindication to MRI (ferro-magnetic surgical clips, eye implants, metallic foreign body intraocular or in the nervous system, implants or metallic objects likely to contain the radiofrequency field, cochlear implants, cerebral or cardiac pacemaker , implantable cardiac defibrillators)
* Patients participating in research involving the therapeutic human person who may modify functional recovery (whether by medication or by medical device) or subject to an exclusion period for another research

Where this trial is running

Paris

• Hôpital Pitié Salpetrière — Paris, France (Recruiting)

Study contacts

• Study coordinator: COHEN Laurent, PUPH

Conditions Ischemic Stroke