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

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy, Refractory
• Intervention / Treatment: Device: macro-micro tetrodes for intracranial recording

Detailed Description

This study would improve the localization of the epileptogenic zone and reduce the overall duration of monitoring, especially in patients who do not experience a sufficient number of seizures during the implantation period. In addition, it would be possible to use micro-electrodes and propose a better surgical treatment to some patients whose preliminary assessment with macro-electrodes has not provided significant results. Finally, the data collected during this study will help us to further understand pathological brain activity and to describe the neuronal circuitry that gives rise to cortical signals and the relationships between them (from spindles to high frequency oscillations).

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrien Peyrache, PhD; Phone Number: 514-398-6780; Email: adrien.peyrache@mcgill.ca
• Study Contact Backup: Name: Birgit Frauscher, MD, PhD; Phone Number: 514-398-1911; Email: birgit.frauscher@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Recruiting
      • McGill University
      • Contact: Adrien Peyrache, PhD; Phone Number: 514-398-6780; Email: adrien.peyrache@mcgill.ca
      • Contact: Birgit Frauscher, PhD, MD; Phone Number: 514-398-1911; Email: birgit.frauscher@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• inclusion criteria is determined based on the clinical diagnosis of the refractory epilepsy and the admissibility of the patient for the stereoelectroencephalography (sEEG) procedure

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micro-macroelectrodes; 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; novel design of tetrode micro electrodes within the standard macro intracranial electrodes used clinically for identification of the epileptogenic zone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency of microelectrodes compared to macroelectrodes	proportion and quality of the FRs recorded by the macro-blocks immediately adjacent to the microelectrodes located in the EZ	10 days after implant

Collaborators and Investigators

• Sponsor: Adrien Peyrache

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 2019-5000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No