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Completed

NCT Number: NCT02491476

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.

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, Midi-Pyrenees, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

intracerebral micro-macroelectrodes

Device

All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluation of the interest of FRs

    Time frame: During 5 days

    Sum of FRs recorded over the 5 days.

  2. 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.

  3. 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.

  4. safety of micro-macroelectrodes

    Time frame: During 5 days

    A quantitative and qualitative description of the side effects associated with the procedure.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Epi-FaR

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2015
Registry last updated
May 6, 2026

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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