NCT05250713

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

January 30, 2022

Last Update Submit

August 5, 2024

Conditions

Epilepsy

Keywords

tDCS (transcranial direct current stimulation)tACS (transcranial alternate current stimulation)Starstimtranscranial stimulationSEEG (stereoelectroencephalography)

Outcome Measures

Primary Outcomes (4)

  • Measure of epileptogenic markers in intracranial brain signals recordings

    Rate and amplitude of interictal epileptogenic spikes

    During tDCS or tACS

  • Measure of epileptogenic markers in intracranial brain signals recordings

    Rate and amplitude of interictal epileptogenic spikes

    After tDCS or tACS

  • Measure of functional connectivity in intracranial brain signals recordings

    Neural network excitability

    During tDCS or tACS

  • Measure of functional connectivity in intracranial brain signals recordings

    Neural network excitability

    After tDCS or tACS

Study Arms (2)

tDCS

EXPERIMENTAL

Patients receiving tDCS during SEEG investigation

Device: Transcranial stimulation

tACS

EXPERIMENTAL

Patients receiving tACS during SEEG intervention

Device: Transcranial stimulation

Interventions

Transcranial stimulationDEVICE

Patients will receive either direct current stimulation or alternate stimulation.

tACStDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Epileptologie et Rythmologie Cérébrale

Marseille, 13005, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • François CREMIEUX

    AP-HM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2022

First Posted

February 22, 2022

Study Start

April 26, 2022

Primary Completion

September 8, 2023

Study Completion

September 22, 2023

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)