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Evaluation of Direct Effects of Electric Fields on Brain (GALVANI PS-2)

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial stimulation
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring tDCS (transcranial direct current stimulation), tACS (transcranial alternate current stimulation), Starstim, transcranial stimulation, SEEG (stereoelectroencephalography)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Male or female, aged ≥ 18 years old
  3. Focal drug-resistant epilepsy
  4. Patient undergoing a clinical SEEG investigation
  5. Stated willingness to comply with all study procedures and availability for the duration of the study
  6. Patient affiliated or beneficiary of a health insurance plan
  7. Patient for whom MRI images (3D T1) are exploitable and fit with the minimum MRI requirements needed for biophysical modelling (cf annex in 14.), prior to SEEG electrodes implantation
  8. Patient for whom a CT-scan with electrodes (or MRI with electrodes) has been realized after SEEG procedure.

Exclusion Criteria:

  1. Difficulty to read or understand the French language, or inability to understand the information regarding the study
  2. Person protected by articles L1121-5, L1121-6 and L1121-8 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults or unable to express their consent). Pregnancy will be evaluated during screening with a urine pregnancy test.
  3. Presence of severe negative outcome of SEEG surgery preventing the acquisition of SEEG data (i.e. hemorragic complications, subcutaneous infection), at the time of inclusion.

  4. Patient showing contraindications for electric stimulation at the time of inclusion:

    (A) Patient with unstable or non-controlled neuropsychiatric illness (B) Patients having cardiac or medication implants (C) Patients with implanted pacemakers (D) Patients with serious brain injury (E) Patients showing damage of skin at sites of stimulation

  5. Any condition that, according to the investigator, is not compatible with carrying out the study

Sites / Locations

  • Service Epileptologie et Rythmologie CérébraleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tDCS

tACS

Arm Description

Patients receiving tDCS during SEEG investigation

Patients receiving tACS during SEEG intervention

Outcomes

Primary Outcome Measures

Measure of epileptogenic markers in intracranial brain signals recordings
Rate and amplitude of interictal epileptogenic spikes
Measure of epileptogenic markers in intracranial brain signals recordings
Rate and amplitude of interictal epileptogenic spikes
Measure of functional connectivity in intracranial brain signals recordings
Neural network excitability
Measure of functional connectivity in intracranial brain signals recordings
Neural network excitability

Secondary Outcome Measures

Full Information

First Posted
January 30, 2022
Last Updated
July 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05250713
Brief Title
Evaluation of Direct Effects of Electric Fields on Brain
Acronym
GALVANI PS-2
Official Title
Quantification of the Immediate Impact of Weak Electric Fields on Brain Activity by SEEG Measurements in Drug-resistant Focal Epilepsy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

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
Transcranial current stimulation (tCS), a safe, tolerable technique employing weak currents (~ 1 mA) applied to the scalp, has been shown to be a promising technique in alleviating seizures in focal epilepsy patients. Although studies reveal a decrease in the epileptiform activity due to tCS, this field lacks a quantification of neurophysiological changes during and immediately after stimulation. The investigators hypothesise that tCS can effectively reduce the amplitude and rate of interictal spikes as well as the functional connectivity between regions during and immediately after stimulation. It is thus planned to deliver an extensive quantitative description of the tCS effects on interictal spike activity, functional connectivity and other tissue biomarkers, using the simultaneous recording of intracranial signals during tCS. Moreover, the investigators seek to compare these variations between different tCS paradigms (direct current -tDCS- vs alternate current -tACS- stimulation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
tDCS (transcranial direct current stimulation), tACS (transcranial alternate current stimulation), Starstim, transcranial stimulation, SEEG (stereoelectroencephalography)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS
Arm Type
Experimental
Arm Description
Patients receiving tDCS during SEEG investigation
Arm Title
tACS
Arm Type
Experimental
Arm Description
Patients receiving tACS during SEEG intervention
Intervention Type
Device
Intervention Name(s)
Transcranial stimulation
Intervention Description
Patients will receive either direct current stimulation or alternate stimulation.
Primary Outcome Measure Information:
Title
Measure of epileptogenic markers in intracranial brain signals recordings
Description
Rate and amplitude of interictal epileptogenic spikes
Time Frame
During tDCS or tACS
Title
Measure of epileptogenic markers in intracranial brain signals recordings
Description
Rate and amplitude of interictal epileptogenic spikes
Time Frame
After tDCS or tACS
Title
Measure of functional connectivity in intracranial brain signals recordings
Description
Neural network excitability
Time Frame
During tDCS or tACS
Title
Measure of functional connectivity in intracranial brain signals recordings
Description
Neural network excitability
Time Frame
After tDCS or tACS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Male or female, aged ≥ 18 years old Focal drug-resistant epilepsy Patient undergoing a clinical SEEG investigation Stated willingness to comply with all study procedures and availability for the duration of the study Patient affiliated or beneficiary of a health insurance plan Patient for whom MRI images (3D T1) are exploitable and fit with the minimum MRI requirements needed for biophysical modelling (cf annex in 14.), prior to SEEG electrodes implantation Patient for whom a CT-scan with electrodes (or MRI with electrodes) has been realized after SEEG procedure. Exclusion Criteria: Difficulty to read or understand the French language, or inability to understand the information regarding the study Person protected by articles L1121-5, L1121-6 and L1121-8 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults or unable to express their consent). Pregnancy will be evaluated during screening with a urine pregnancy test. Presence of severe negative outcome of SEEG surgery preventing the acquisition of SEEG data (i.e. hemorragic complications, subcutaneous infection), at the time of inclusion. Patient showing contraindications for electric stimulation at the time of inclusion: (A) Patient with unstable or non-controlled neuropsychiatric illness (B) Patients having cardiac or medication implants (C) Patients with implanted pacemakers (D) Patients with serious brain injury (E) Patients showing damage of skin at sites of stimulation Any condition that, according to the investigator, is not compatible with carrying out the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Bartolomei
Phone
0491385829
Email
fabrice.bartolomei@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
AP-HM
Official's Role
Study Director
Facility Information:
Facility Name
Service Epileptologie et Rythmologie Cérébrale
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice BARTOLOMEI
Email
fabrice.bartolomei@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Sophie Tardoski
Email
sophie.tardoski@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Direct Effects of Electric Fields on Brain

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