TIS for Drug Resistant TLE (TITE-Effect)

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Epilepsy

Treatments: Device: TI Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07519018

KY20262074

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 to 65 years old;
2. According to the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;
3. Temporal lobe epilepsy assessed by semiology, video electroencephalogram, and imaging;
4. The duration of epilepsy was ≥2 years, and the average seizure frequency was ≥2 times per month in the 3 months before enrollment;
5. Taking two or more antiepileptic drugs and continuing the same drug regimen for the duration of the trial;
6. Could cooperate with the completion of treatment and related examinations;
7. Patients and their family members fully understood and voluntarily signed the informed consent.

Exclusion criteria

1. The anti-seizure medication therapy was adjusted during the treatment and follow-up period;
2. Patient in status epilepticus;
3. Patient with other systemic diseases leading to nervous system involvement and seizures;
4. 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;
5. Patient with pregnant or lactating;
6. Patients with contraindications to TI stimulation, fMRI examination or EEG examination, metal implants (pacemakers, metal dentures, metal IUD rings, etc.), or claustrophobia;
7. Participating in other clinical trials;
8. Patients or their family members withdrew informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Temporal interference

Experimental group

Treatment:

Device: TI Stimulation