NCT07519018
Not yet recruiting
Not Applicable
Study on the Effect of Temporal Interference Stimulation in the Therapy of Drug Resistant Temporal Lobe Epilepsy
Xijing Hospital0 sites30 target enrollmentStarted: April 15, 2026Last updated:
ConditionsEpilepsy
InterventionsTI Stimulation
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Xijing Hospital
- Enrollment
- 30
- Primary Endpoint
- Seizure Frequency Rate Change of One Month
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- •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.
Arms & Interventions
Temporal interference
Experimental
Intervention: TI Stimulation (Device)
Outcomes
Primary Outcomes
Seizure Frequency Rate Change of One Month
Time Frame: One month after treatment
Secondary Outcomes
- Rate of Seizure Frequency Rate Change of Two Month(Two month after treatment)
- Electroencephalogram Change(Baseline, 24 hours after treatment, one month after treatment, two months after treatment)
Investigators
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