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Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy (GALVANI PS-1)

Primary Purpose

Epilepsy

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring pharmaco-resistant epilepsy, transcranial stimulation, SEEG

Eligibility Criteria

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

Inclusion Criteria:

- Age: Older than 12 years old
Patients with drug-resistant focal epilepsy with no surgical indication or with a previous surgical failure or refusing surgery.
SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone
A clinical or research MRI scan that is suitable for navigated brain stimulation (NBS) and definition of target area.
Number of seizures >3/month during the baseline (before the first session of tDCS treatment), for at least 3 months
Have stable medications for the whole study duration and few weeks before
Total IQ>65
Be able to understand, speak and write in French
Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures,
Be a beneficiary of affiliated to a health insurance plan

Exclusion Criteria:

- Generalized epilepsy
Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor
Skin conditions (e.g., eczema, lesion)
Any cranial metal implants (excluding <1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant).
Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
Metal inside the head (outside the mouth) such as shrapnel, surgical clips
Patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion.
Any condition that makes the study subject, in the opinion of the investigator, unsuitable for 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 unable or unable to express their consent).

Sites / Locations

Service d'Epileptologie et de Rythmologie Cérébrale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS (transcranial direct current stimulation)

Arm Description

Patient will be treated for 3 cycles. A cycle is composed of 5 bi-sessions (one per day) of 20 minutes each.

Outcomes

Primary Outcome Measures

Seizure frequency

Percentage of change of seizures frequency

Seizure frequency

Percentage of change of seizures frequency

Seizure frequency

Percentage of change of seizures frequency

Seizure frequency

Percentage of change of seizures frequency

Secondary Outcome Measures

Depression

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) - score to 6 to 24, higher values mean worse outcome

Anxiety disorders

Generalized Anxiety Disorder-7 (GAD-7) - score between 0 to 21, higher values mean worse outcome

Seizures evaluation

National Hospital Seizure Severity Scale (NHS3) - score 1 to 31, higher values mean worse outcome

Brain functional connectivity

National Hospital Seizure Severity Scale (NHS3) score 1 to 31, higher values mean worse outcome

Full Information

NCT ID

NCT04782869

First Posted

February 26, 2021

Last Updated

July 19, 2023

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT04782869

Brief Title

Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy

Acronym

GALVANI PS-1

Official Title

Personalized Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: Evaluation of Therapeutic and Neurophysiological Effects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 15, 2021 (Actual)

Primary Completion Date

February 20, 2023 (Actual)

Study Completion Date

October 31, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This project aims to conduct a pilot study based on the targeting of the epileptogenic zone previously localized very precisely by stereoelectroencephalography (SEEG). SEEG is used as part of the pre-surgical assessment. It consists, thanks to the intracerebral implantation of electrodes in the brain of patients, to perform an intracerebral electrophysiological recording and thus to precisely explore the epileptogenic regions. In order to study the neuromodulatory and therapeutic effects of tDCS on epileptic brains, non-invasive techniques for measuring electrophysiological brain activity such as magnetoencephalography (MEG) and high-resolution electroencephalography (HR EEG) will be used. Finally, since epilepsy is considered to be a disorder of brain functional networks associated with disturbed brain connectivity, the effects of tDCS on cortical excitability by studying the variations in functional connectivity induced by stimulation will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

pharmaco-resistant epilepsy, transcranial stimulation, SEEG

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS (transcranial direct current stimulation)

Arm Type

Experimental

Arm Description

Patient will be treated for 3 cycles. A cycle is composed of 5 bi-sessions (one per day) of 20 minutes each.

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Intervention Description

Patients will be treated using Starstim 8 device, a device allowing to perform transcranial direct current stimulation. The position of electrodes will be personalized based on the localization of the epileptogenic zone.

Primary Outcome Measure Information:

Title

Seizure frequency

Description

Percentage of change of seizures frequency

Time Frame

Comparison between baseline and month 2

Title

Seizure frequency

Description

Percentage of change of seizures frequency

Time Frame

Comparison between baseline and month 4

Title

Seizure frequency

Description

Percentage of change of seizures frequency

Time Frame

Comparison between baseline and month 6

Title

Seizure frequency

Description

Percentage of change of seizures frequency

Time Frame

Comparison between baseline and month 8

Secondary Outcome Measure Information:

Title

Depression

Description

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) - score to 6 to 24, higher values mean worse outcome

Time Frame

Comparison between baseline and month 8

Title

Anxiety disorders

Description

Generalized Anxiety Disorder-7 (GAD-7) - score between 0 to 21, higher values mean worse outcome

Time Frame

Comparison between baseline and month 8

Title

Seizures evaluation

Description

National Hospital Seizure Severity Scale (NHS3) - score 1 to 31, higher values mean worse outcome

Time Frame

Comparison between baseline and month 8

Title

Brain functional connectivity

Description

National Hospital Seizure Severity Scale (NHS3) score 1 to 31, higher values mean worse outcome

Time Frame

Comparison between day 1 and day 5 of each session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Age: Older than 12 years old Patients with drug-resistant focal epilepsy with no surgical indication or with a previous surgical failure or refusing surgery. SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone A clinical or research MRI scan that is suitable for navigated brain stimulation (NBS) and definition of target area. Number of seizures >3/month during the baseline (before the first session of tDCS treatment), for at least 3 months Have stable medications for the whole study duration and few weeks before Total IQ>65 Be able to understand, speak and write in French Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures, Be a beneficiary of affiliated to a health insurance plan Exclusion Criteria: - Generalized epilepsy Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor Skin conditions (e.g., eczema, lesion) Any cranial metal implants (excluding <1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm. Metal inside the head (outside the mouth) such as shrapnel, surgical clips Patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion. Any condition that makes the study subject, in the opinion of the investigator, unsuitable for 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 unable or unable to express their consent).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Olivier Arnaud

Organizational Affiliation

AP-HM

Official's Role

Study Director

Facility Information:

Facility Name

Service d'Epileptologie et de Rythmologie Cérébrale

City

Marseille

ZIP/Postal Code

13005

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy

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