Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy (Epi-FaR)

June 5, 2023 updated by: University Hospital, Toulouse

Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Partial epilepsies are refractory to medical treatment in 30% of the cases (Refractory Partial Epilepsy or RPE). Patients with RPE suffer from social and occupational disability, an increased risk associated with seizures (traumatic brain injury, accidents), but also a higher risk of sudden unexplained death (2 to 3 times higher) than the general population. Moreover, the medical and social burden of these patients is heavy, representing a significant cost to society.

In some cases, surgical treatment with resection of the epileptogenic zone (EZ) can be proposed. The presurgical evaluation includes various investigations seeking to clarify the location of the EZ; but this approach is sometimes insufficient and the definition of the EZ then requires invasive exploration through intracerebral EEG recording (stereo-EEG, SEEG). This latter technique is currently the preferred standard to define the EZ. It involves implanting electrodes in the brain areas suspected to belong to the seizure network. 50 to 70% of patients investigated with this technique will have epilepsy surgery.

In recent years, a series of studies in animals and humans have suggested that some oscillations, very short and at very high frequency (> 250 Hz), called "fast ripples" (FRs) could be a good biomarker of the EZ (for a review see Zijlmans et al, 2012). The FRs are more easily recorded from microelectrode (diameter: 20-40 microns).

The purpose of this study is to evaluate a new medical device designed by DixiMedical to record FRs, combining micro and regular clinical electrodes.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Midi-Pyrenees
      • Toulouse, Midi-Pyrenees, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with RPE in whom SEEG is required to precisely localize the seizure focus

Exclusion Criteria:

Patients with SEEG contra-indication:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: micro-macroelectrodes
All patients will be implanted with usually 4 intracerebral micro-macroelectrodes(replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.
Device: intracerebral micro-macroelectrodes
All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the feasibility of recording Fast Ripples (FRs)
Time Frame: During 5 days
Proportion of patients who are registered more than 60 FRs per hour the day 3 and the day 4 on the micro-macro electrode in the presumed epileptogenic zone, compared to the number of patients included
During 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the interest of FRs
Time Frame: During 5 days
Sum of FRs recorded over the 5 days.
During 5 days
Evolution of the hourly frequency of FRs
Time Frame: During 5 days
The evolution of the hourly frequency of FRs recorded by the microelectrodes depending on the day of recording.
During 5 days
Effectiveness of microelectrodes and macroelectrodes
Time Frame: During 5 days
Number of FRs stored on the macro-blocks immediately adjacent to the microelectrodes located in the EZ.
During 5 days
safety of micro-macroelectrodes
Time Frame: During 5 days
A quantitative and qualitative description of the side effects associated with the procedure.
During 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France
DIXI Medical, Besançon, France

Investigators

  • Principal Investigator: Luc VALTON, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

August 18, 2022

Study Completion (Actual)

September 18, 2022

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimated)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/13/6899
  • 2014-A00747-40 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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