TIS for Drug Resistant TLE

NCT07519018 | Not Yet Recruiting

• 1 other identifier: KY20262074
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Keywords

TIS; TLE

Outcome Measures

Primary Outcomes (1)

• Seizure Frequency Rate Change of One Month

  One month after treatment

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• fMRI Change

  Baseline, the moment after the first TI stimulation

Study Arms (1)

Temporal interference

EXPERIMENTAL

Device: TI Stimulation

Interventions

TI Stimulation DEVICE

Temporal interference (TI) targeting hippocampus for 5 days.

Temporal interference

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share