Using Micro-filaments to Detect "fast Ripples" and Improve the Identification of the Epileptogenic Zone

NCT05254730 | Recruiting

• 1 other identifier: 2019-5000
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

record fast ripples with novel intracranial electrodes with micro-tetrodes to improve the identification of epileptogenic zone (EZ) and investigate the neuronal circuits underlying brain dynamics associated with epilepsy

Conditions

Epilepsy, Refractory

Outcome Measures

Primary Outcomes (1)

• evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes

  sum of number of single units recorded and the number of fast ripples (FRs)

  1 week after implant

Secondary Outcomes (1)

• Efficiency of microelectrodes compared to macroelectrodes

  10 days after implant

Study Arms (1)

micro-macroelectrodes

EXPERIMENTAL

Patients will be implanted with usually the novel intracerebral micro-macroelectrodes (instead of the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.

Device: macro-micro tetrodes for intracranial recording

Interventions

macro-micro tetrodes for intracranial recording DEVICE

novel design of tetrode micro electrodes within the standard macro intracranial electrodes used clinically for identification of the epileptogenic zone

micro-macroelectrodes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• severe psychiatric disorders,
• severe agitation during their crisis
• contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system,
• contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women,
• anti thrombotic ongoing treatment.

Sponsors & Collaborators

• Adrien Peyrache: lead

Study Sites (1)

McGill University

Montreal, Quebec, H3A 2B4, Canada

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Adrien Peyrache, PhD

CONTACT

514-398-6780; adrien.peyrache@mcgill.ca

Birgit Frauscher, MD, PhD

CONTACT

514-398-1911; birgit.frauscher@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CA (1)