Intracerebral Electrical Stimulation and the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy

NCT03738072 | Recruiting

• 1 other identifier: RC31/17/0345
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

Conditions

Epilepsy

Keywords

Epilepsy; Electrical Brain stimulation; Neurosurgery; stereo-electro-encephalography (SEEG)

Outcome Measures

Primary Outcomes (1)

• Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition

  Comparison for each patient of the index of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect over the total number of stimulations) for each condition (standard clinical stimulations condition vs research stimulations condition).

  22 days after implantation of electrode

Secondary Outcomes (4)

• efficient stimulation for each frequency of stimulation

  22 days after implantation of electrode

• efficient stimulation for each type of brain area stimulated

  22 days after implantation of electrode

• percentage change in the neuronal discharge rate

  30 second after stimulation

• percentage change in the neuronal discharge rate for stimic stimulation condition

  30 second after stimulation

Study Arms (1)

StiMic stimulation condition

EXPERIMENTAL

StiMic stimulation condition will be evaluate during stereo-electro-encephalography and this condition will be compare to standard stimulation condition

Diagnostic Test: StiMiC stimulation condition

Interventions

StiMiC stimulation condition DIAGNOSTIC_TEST

This new condition of stimulation of electrical Brain Stimulation will be evaluate to determine if this stimulation is more efficient that standard stimulation condition

StiMic stimulation condition

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:

• all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old.

You may not qualify if:

• usual excluding criteria for a SEEG.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, 3100, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jonathan Curot, MD

  CHU of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Curot, MD

CONTACT

05 61 77 56 08; curot.j@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: November 14, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)