TIS for Drug Resistant TLE (TITE-Effect)

April 9, 2026 updated by: Xijing Hospital

Study on the Effect of Temporal Interference Stimulation in the Therapy of Drug Resistant Temporal Lobe Epilepsy

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temporal interference
Device: TI Stimulation
Temporal interference (TI) targeting hippocampus for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seizure Frequency Rate Change of One Month
Time Frame: One month after treatment
One month after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Electroencephalogram Change
Time Frame: Baseline, 24 hours after treatment, one month after treatment, two months after treatment
Baseline, 24 hours after treatment, one month after treatment, two months after treatment
Rate of Seizure Frequency Rate Change of Two Month
Time Frame: Two month after treatment
Two month after treatment

Other Outcome Measures

Outcome Measure
Time Frame
fMRI Change
Time Frame: Baseline, the moment after the first TI stimulation
Baseline, the moment after the first TI stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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