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NCT Number: NCT05254730

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

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

macro-micro tetrodes for intracranial recording

Device

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

Primary outcomes

  1. evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes

    Time frame: 1 week after implant

    sum of number of single units recorded and the number of fast ripples (FRs)

Secondary outcomes

  1. Efficiency of microelectrodes compared to macroelectrodes

    Time frame: 10 days after implant

    proportion and quality of the FRs recorded by the macro-blocks immediately adjacent to the microelectrodes located in the EZ

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien Peyrache, PhD

CONTACT

[email protected]

514-398-6780

Birgit Frauscher, MD, PhD

CONTACT

[email protected]

514-398-1911

Sponsors and collaborators

Lead sponsor

Adrien Peyrache

Other

Registry information

Acronym: NeuroSeizure

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Feb 24, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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