Recruiting

Epileptogenic Zone

Sponsor:

Adrien Peyrache

Code:

NCT05254730

Conditions

Epilepsy, Refractory

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

macro-micro tetrodes for intracranial recording

Study Details

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

Study ID

NCT05254730

Start date

Sep 1, 2023

Status verified date

Nov, 2024

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes [ Time Frame: 1 week after implant ]

Central Contacts and Locations

Central contacts

Locations

McGill University

Recruiting

Montreal, Quebec, Canada, H3A 2B4

Contacts

More Information

Sponsor

Adrien Peyrache

Last update posted

Nov 20, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Adrien Peyrache on 2024-11-20.