Effects of Mepivacaine on the Neurological Sequelae of Cerebral Infarction

• Status: Not yet recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: All

Summary

A patient, suffering from cortical blindness after a bi-occipital infarction 1 year earlier, regained near-normal vision in the right visual hemifield a few minutes after subcutaneous administration of mepivacaine. The effect was maintained for several days, and was repeated with each injection of mepivacaine. This clinical improvement is associated with functional changes in the peri-lesional areas on resting-state functional MRI.

The investigator team hypothesizes that in some patients with chronic neurological symptoms of stroke, we will observe a favorable response to subcutaneous mepivacaine injection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Mepivacaine

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