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

Epilepsy Clinical Trial

— GALVANI PS-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782869
• Other study ID #: 2020-55
• Secondary ID: ID-RCB
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: February 21, 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 21, 2024
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Device:
• transcranial direct current stimulation
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.

Locations

Country	Name	City	State
France	Service d'Epileptologie et de Rythmologie Cérébrale	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency	Percentage of change of seizures frequency	Comparison between baseline and month 2
Primary	Seizure frequency	Percentage of change of seizures frequency	Comparison between baseline and month 4
Primary	Seizure frequency	Percentage of change of seizures frequency	Comparison between baseline and month 6
Primary	Seizure frequency	Percentage of change of seizures frequency	Comparison between baseline and month 8
Secondary	Depression	Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) - score to 6 to 24, higher values mean worse outcome	Comparison between baseline and month 8
Secondary	Anxiety disorders	Generalized Anxiety Disorder-7 (GAD-7) - score between 0 to 21, higher values mean worse outcome	Comparison between baseline and month 8
Secondary	Seizures evaluation	National Hospital Seizure Severity Scale (NHS3) - score 1 to 31, higher values mean worse outcome	Comparison between baseline and month 8
Secondary	Brain functional connectivity	National Hospital Seizure Severity Scale (NHS3) score 1 to 31, higher values mean worse outcome	Comparison between day 1 and day 5 of each session