Evaluation of Direct Effects of Electric Fields on Brain (NCT05250713) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Direct Effects of Electric Fields on Brain
France12 participantsStarted 2022-04-26
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure of epileptogenic markers in intracranial brain signals recordings
Timeframe: During tDCS or tACS
2
Measure of epileptogenic markers in intracranial brain signals recordings
Timeframe: After tDCS or tACS
3
Measure of functional connectivity in intracranial brain signals recordings
Timeframe: During tDCS or tACS
4
Measure of functional connectivity in intracranial brain signals recordings
. 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:
. Any condition that, according to the investigator, is not compatible with carrying out the study