Status:
RECRUITING
Effects of Mepivacaine on the Neurological Sequelae of Cerebral Infarction
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 o...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 22 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05222828
Start Date
June 22 2022
End Date
June 22 2024
Last Update
January 26 2024
Active Locations (1)
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1
Hôpital Pitié Salpetrière
Paris, France, 75013