NCT07082101

Brief Summary

This study evaluates the effect of temporal interference (TI) stimulation on biomarkers in patients with temporal lobe epilepsy (TLE) under stereo-electroencephalography (SEEG), and provides theoretical basis for non-invasive TI treatment of temporal lobe epilepsy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

June 29, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

July 24, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

June 29, 2025

Last Update Submit

July 22, 2025

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Number of interictal electrophysiological biomaker changes in epilepsy

    Electrophysiological biomarkers changes recorded by SEEG through the experiment.

    24 hours after TI stimulation

Study Arms (1)

Temporal interference

EXPERIMENTAL
Other: temporal interference

Interventions

temporal interferenceOTHER

In this intervertion, patients with SEEG operation will take temporal interference (TI) stimulation and the deep brain EEG will be monitorated through the entire experiment.

Temporal interference

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of drug refractory epilepsy and temporal lobe epilepsy;
  • Patients undergoing SEEG;
  • Able to cooperate the treatment and related inspection;
  • Fully understands and signs informed consent.

You may not qualify if:

  • Patients with temporal plus epilepsy;
  • In status epilepticus;
  • With other severe disease;
  • Pregnancy or lactation women;
  • Unable to tolerate SEEG or TI;
  • At the same time to participate in other clinical trials;
  • Withdraw consent procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Wen Jiang

CONTACT

+86-02984773664jiangwen@fmmu.edu.cn

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

June 29, 2025

First Posted

July 24, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

July 24, 2025

Record last verified: 2025-06

Locations

CN(1)