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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05250713
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Device: Transcranial stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Quantification of the Immediate Impact of Weak Electric Fields on Brain Activity by SEEG Measurements in Drug-resistant Focal Epilepsy Patients
• Actual Study Start Date: Apr 26, 2022
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS Patients receiving tDCS during SEEG investigation	Device: Transcranial stimulation; Patients will receive either direct current stimulation or alternate stimulation.
Experimental: tACS Patients receiving tACS during SEEG intervention	Device: Transcranial stimulation; Patients will receive either direct current stimulation or alternate stimulation.

Outcome Measures

Primary Outcome Measures

1. Measure of epileptogenic markers in intracranial brain signals recordings [During tDCS or tACS]

   Rate and amplitude of interictal epileptogenic spikes

2. Measure of epileptogenic markers in intracranial brain signals recordings [After tDCS or tACS]

   Rate and amplitude of interictal epileptogenic spikes

3. Measure of functional connectivity in intracranial brain signals recordings [During tDCS or tACS]

   Neural network excitability

4. Measure of functional connectivity in intracranial brain signals recordings [After tDCS or tACS]

   Neural network excitability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service Epileptologie et Rythmologie Cérébrale	Marseille		France	13005

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: François CREMIEUX, AP-HM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT05250713
• Other Study ID Numbers: 2020-66; ID-RCB
• First Posted: Feb 22, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique Hopitaux De Marseille: tDCS (transcranial direct current stimulation); tACS (transcranial alternate current stimulation); Starstim; transcranial stimulation; SEEG (stereoelectroencephalography)
• Additional relevant MeSH terms: Epilepsy

Study Results

No Results Posted as of Aug 2, 2022