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

Epilepsy, Refractory Clinical Trial

— NeuroSeizure  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254730
• Other study ID #: 2019-5000
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: McGill University
• Contact: Adrien Peyrache, PhD
• Phone: 514-398-6780
• Email: adrien.peyrache[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy, Refractory

Intervention

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

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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