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Recruiting NCT05254730

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

No phase Interventional Epilepsy, Refractory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: macro-micro tetrodes for intracranial recording.
Who it may be relevant to
Registry conditions: Epilepsy, Refractory. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • 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

Primary outcome measures

  • evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes [Time frame: 1 week after implant]
Secondary outcome measures (1)
  • Efficiency of microelectrodes compared to macroelectrodes [Time frame: 10 days after implant]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Canada · 1 center
  • McGill University — Montreal

Identifiers

NCT: NCT05254730 · 2019-5000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗