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

Not Applicable

Recruiting

• Conditions: Epilepsy, Refractory
• Interventions: Device: macro-micro tetrodes for intracranial recording

• Registration Number: NCT05254730
• Lead Sponsor: Adrien Peyrache

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

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 Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Study Start: 2023-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2026-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
micro-macroelectrodes	macro-micro tetrodes for intracranial recording	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.

Primary Outcome Measures

Name	Time	Method
evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes	1 week after implant	sum of number of single units recorded and the number of fast ripples (FRs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

McGill University; 🇨🇦 Montreal, Quebec, Canada