Temporal Interference for Temporal Lobe Epilepsy Under SEEG

NCT ID: NCT07082101

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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10 patients aged 18-65 years with TLE assessed by semiology, video electroencephalogram and imaging in Epilepsy Center of Xijing Hospital (Xi'an, China) will be recruited. Clinical baseline data such as general information and history of seizures will be collected. The SEEG electrodes were implanted in the Department of neurosurgery of Xijing Hospital and after 24 hours TI will be performed with continuous SEEG monitoring. Finally, the biomarker changes of EEG signals before and after TI treatment were statistically analyzed.

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Temporal interference

Group Type EXPERIMENTAL

temporal interference

Intervention Type OTHER

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.

Interventions

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temporal interference

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Wen Jiang

Role: CONTACT

+86-02984773664

Facility Contacts

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Wen Jiang

Role: primary

+86-02984773664

Other Identifiers

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KY20252287

Identifier Type: -

Identifier Source: org_study_id

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