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

NCT02491476 | Completed DMC

• 2 other identifiers: RC31/13/68992014-A00747-40
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Keywords

Safety; Electrodes; Device; StereoElectroencephalograph; Epileptogenic zone; Fast ripples

Outcome Measures

Primary Outcomes (1)

• Evaluation of the feasibility of recording Fast Ripples (FRs)

  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 Outcomes (4)

• Evaluation of the interest of FRs

  During 5 days

• Evolution of the hourly frequency of FRs

  During 5 days

• Effectiveness of microelectrodes and macroelectrodes

  During 5 days

• safety of micro-macroelectrodes

  During 5 days

Study Arms (1)

micro-macroelectrodes

EXPERIMENTAL

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

Interventions

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.

micro-macroelectrodes

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France: collaborator
• DIXI Medical, Besançon, France: collaborator

Study Sites (1)

University Hospital Toulouse

Toulouse, Midi-Pyrenees, 31059, France

Location

Related Publications (1)

• Despouy E, Curot J, Denuelle M, Deudon M, Sol JC, Lotterie JA, Reddy L, Nowak LG, Pariente J, Thorpe SJ, Valton L, Barbeau EJ. Neuronal spiking activity highlights a gradient of epileptogenicity in human tuberous sclerosis lesions. Clin Neurophysiol. 2019 Apr;130(4):537-547. doi: 10.1016/j.clinph.2018.12.013. Epub 2019 Jan 30.

  PMID: 30785010 RESULT

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• luc valton, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: July 8, 2015
• Study Start: March 1, 2015
• Primary Completion: August 18, 2022
• Study Completion: September 18, 2022
• Last Updated: May 6, 2026

Record last verified: 2023-06

Locations

FR (1)