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

NCT ID: NCT05254730

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2028-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy, Refractory

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

macro-micro tetrodes for intracranial recording

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Adrien Peyrache

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adrien Peyrache

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McGill University

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Adrien Peyrache, PhD

Role: CONTACT

514-398-6780

Birgit Frauscher, MD, PhD

Role: CONTACT

514-398-1911

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adrien Peyrache, PhD

Role: primary

514-398-6780

Birgit Frauscher, PhD, MD

Role: backup

514-398-1911

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-5000

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Microelectrodes in Epilepsy
NCT05200455 COMPLETED NA