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NCT Number: NCT07519018

TIS for Drug Resistant TLE

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TI Stimulation

Device

Temporal interference (TI) targeting hippocampus for 5 days.

Primary outcomes

  1. Seizure Frequency Rate Change of One Month

    Time frame: One month after treatment

Secondary outcomes

  1. Rate of Seizure Frequency Rate Change of Two Month

    Time frame: Two month after treatment

  2. Electroencephalogram Change

    Time frame: Baseline, 24 hours after treatment, one month after treatment, two months after treatment

Other outcomes

  1. fMRI Change

    Time frame: Baseline, the moment after the first TI stimulation

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Acronym: TITE-Effect

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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