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

Primary Purpose

Epilepsy, Refractory

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
macro-micro tetrodes for intracranial recording
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy, Refractory

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

micro-macroelectrodes

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2022
Last Updated
September 29, 2023
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT05254730
Brief Title
Using Micro-filaments to Detect "Fast Ripples" and Improve the Identification of the Epileptogenic Zone
Acronym
NeuroSeizure
Official Title
Using Micro-filaments to Detect "Fast Ripples" and Improve the Identification of the Epileptogenic Zone
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Refractory

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
micro-macroelectrodes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
macro-micro tetrodes for intracranial recording
Intervention Description
novel design of tetrode micro electrodes within the standard macro intracranial electrodes used clinically for identification of the epileptogenic zone
Primary Outcome Measure Information:
Title
evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes
Description
sum of number of single units recorded and the number of fast ripples (FRs)
Time Frame
1 week after implant
Secondary Outcome Measure Information:
Title
Efficiency of microelectrodes compared to macroelectrodes
Description
proportion and quality of the FRs recorded by the macro-blocks immediately adjacent to the microelectrodes located in the EZ
Time Frame
10 days after implant

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrien Peyrache, PhD
Phone
514-398-6780
Email
adrien.peyrache@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Birgit Frauscher, MD, PhD
Phone
514-398-1911
Email
birgit.frauscher@mcgill.ca
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien Peyrache, PhD
Phone
514-398-6780
Email
adrien.peyrache@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Birgit Frauscher, PhD, MD
Phone
514-398-1911
Email
birgit.frauscher@mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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