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

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
StiMiC stimulation condition
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring Epilepsy, Electrical Brain stimulation, Neurosurgery, stereo-electro-encephalography (SEEG)

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • usual excluding criteria for a SEEG.

Sites / Locations

  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

StiMic stimulation condition

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

efficient stimulation for each frequency of stimulation
Distribution of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect) for each frequency of stimulation.
efficient stimulation for each type of brain area stimulated
Distribution of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect) for each type of brain area stimulated (i.e, anatomical brain area, seizure onset zone, primary seizure propagation zone, healthy brain area or lesion).
percentage change in the neuronal discharge rate
Percentage change in the neuronal discharge rate 30 seconds after the stimulation compared to the 30 seconds before the stimulation, depending on the frequency of stimulations.
percentage change in the neuronal discharge rate for stimic stimulation condition
Percentage change in the neuronal discharge rate 30 seconds after the stimulation compared to the 30 seconds before the stimulation, depending on the effect of the stimulation (electrical or clinical as defined in the primary outcome)

Full Information

First Posted
November 8, 2018
Last Updated
June 19, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03738072
Brief Title
Intracerebral Electrical Stimulation and the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy
Acronym
StiMiC
Official Title
A Study of the Effect of Intracerebral Electrical Stimulation on the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy (StiMiC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

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

5. Study Description

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.
Detailed Description
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 brain electrical stimulations is a standard clinical practice to assess seizure sensitivity and for functional mapping. However the efficiency of these stimulations can be questioned and could potentially be improved. Indeed, only two typical frequencies are commonly used in our epilepsy centre, 1Hz and 50Hz, without clear clinical or scientific justification for these specific frequencies. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies could improve the definition of the seizure onset zone and hence the presurgical planning. We will maintain the usual stimulation frequencies (standard clinical stimulations condition) and add new frequencies to the protocol (research stimulations condition). The choice of these new frequencies will be based either on the spontaneous frequency of the onset of the patients' typical seizures or on physiological frequencies depending on the brain structures stimulated (i.e., theta in the medial temporal lobe). The protocol will be proposed to all patients undergoing a stereo-electro-encephalography (SEEG) in our epilepsy center and the efficiency of the two conditions (standard clinical stimulations condition vs research stimulations condition) will be compared. The efficiency will be assessed as any epileptic event, recorded in the intracerebral EEG or symptom induced by the stimulations. This project will last 36 months. 20 patients will be included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Electrical Brain stimulation, Neurosurgery, stereo-electro-encephalography (SEEG)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
StiMic stimulation condition
Arm Type
Experimental
Arm Description
StiMic stimulation condition will be evaluate during stereo-electro-encephalography and this condition will be compare to standard stimulation condition
Intervention Type
Diagnostic Test
Intervention Name(s)
StiMiC stimulation condition
Intervention Description
This new condition of stimulation of electrical Brain Stimulation will be evaluate to determine if this stimulation is more efficient that standard stimulation condition
Primary Outcome Measure Information:
Title
Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition
Description
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).
Time Frame
22 days after implantation of electrode
Secondary Outcome Measure Information:
Title
efficient stimulation for each frequency of stimulation
Description
Distribution of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect) for each frequency of stimulation.
Time Frame
22 days after implantation of electrode
Title
efficient stimulation for each type of brain area stimulated
Description
Distribution of efficient stimulations (assessed as any stimulation having yielded an electrical or clinical effect) for each type of brain area stimulated (i.e, anatomical brain area, seizure onset zone, primary seizure propagation zone, healthy brain area or lesion).
Time Frame
22 days after implantation of electrode
Title
percentage change in the neuronal discharge rate
Description
Percentage change in the neuronal discharge rate 30 seconds after the stimulation compared to the 30 seconds before the stimulation, depending on the frequency of stimulations.
Time Frame
30 second after stimulation
Title
percentage change in the neuronal discharge rate for stimic stimulation condition
Description
Percentage change in the neuronal discharge rate 30 seconds after the stimulation compared to the 30 seconds before the stimulation, depending on the effect of the stimulation (electrical or clinical as defined in the primary outcome)
Time Frame
30 second after stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old. Exclusion Criteria: usual excluding criteria for a SEEG.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Curot, MD
Phone
05 61 77 56 08
Ext
33
Email
curot.j@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Curot, MD
Organizational Affiliation
CHU of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
3100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Curot, MD
Email
curot.j@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Marie Denuelle, MD
Email
denuelle.m@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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