Effects of Mepivacaine on the Neurological Sequelae of Cerebral Infarction

NCT05222828 | Unknown Phase 2

• 2 other identifiers: APHP1907232021-005507-13
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 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, the investigator team will observe a favorable response to subcutaneous mepivacaine injection.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• improvement of clinical scores

  The response is defined as an improvement 1h (+/- 30min) after injection, compared to the evaluation before mepivacaine injection, on at least one of the clinical scores specific to the symptoms: * language : decrease of at least 4 points on the ART scale (rated from 0 to 26) , or increase of 20% of the number of images correctly named on a standardized battery (DO80, rated from 0 to 80). The rate of 20% corresponds to an effect considered clinically significant, without any "clinically significant minimal change" published to date. * motor skills : increase of at least 4 points on the Fugl-Meyer scale (rated from 0 to 60) corresponding to the "clinically significant minimal change" in the re-education studies * visual field : 20% reduction of a scotoma evaluated in automated static perimetry of Humphrey by the number of deficit areas compared to the total number of areas evaluated (n=43). The rate of 20% corresponds to an effect considered clinically significant

  1 Day

Secondary Outcomes (11)

• language-related symptoms

  1 Day

• ART scale

  1 Day

• spontaneous language test

  1 Day

• Fugl-Meyer scale

  1Day

• Timed up and go test

  1Day

Study Arms (1)

Mepivacaine arm

EXPERIMENTAL

mepivacaine injection

Drug: Carbocaine Injectable Product

Interventions

Carbocaine Injectable Product DRUG

One injection per patient

Mepivacaine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpetrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

COHEN Laurent, PUPH

CONTACT

142161801; laurent.cohen@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: June 22, 2022
• Primary Completion: June 22, 2024
• Study Completion: June 22, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

FR (1)