TIS for Drug Resistant TLE (NCT07519018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TIS for Drug Resistant TLE
30 participantsStarted 2026-04-15
Plain-language summary
Temporal interference (TI) stimulation is a new neuromodulation method. Compared with traditional neuromodulation therapy, TI has deep targeting and focusing, and it has been confirmed to modulate sleep, cognition, and movement disorders. Recent study shown that TI stimulation targeting the hippocampus could significantly reduce epileptiform discharges, but its efficacy on seizures was still unclear. Therefore, the aim of this study is to observe the therapeutic effect of TI stimulation targeting the hippocampus in patients with refractory temporal lobe epilepsy (TLE) for 5 days, and to provide support for clinical trials of non-invasive treatment of refractory TLE.
Who can participate
Age range
18 Years – 65 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
. 18 to 65 years old;
. According to the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;
. Temporal lobe epilepsy assessed by semiology, video electroencephalogram, and imaging;
. The duration of epilepsy was ≥2 years, and the average seizure frequency was ≥2 times per month in the 3 months before enrollment;
. Taking two or more antiepileptic drugs and continuing the same drug regimen for the duration of the trial;
. Could cooperate with the completion of treatment and related examinations;
. Patients and their family members fully understood and voluntarily signed the informed consent.
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.
. The anti-seizure medication therapy was adjusted during the treatment and follow-up period;
. Patient in status epilepticus;
. Patient with other systemic diseases leading to nervous system involvement and seizures;
. Patients with severe infection, cerebrovascular disease, malignant tumor and other diseases, accompanied by severe dysfunction of heart, liver, kidney and other organs, or accompanied by severe mental or cognitive impairment, or intractable hyperglycemia, or long-term use of corticosteroids;
. Patient with pregnant or lactating;
. Patients with contraindications to TI stimulation, fMRI examination or EEG examination, metal implants (pacemakers, metal dentures, metal IUD rings, etc.), or claustrophobia;
. Participating in other clinical trials;
. Patients or their family members withdrew informed consent.