Temporal Interference for Temporal Lobe Epilepsy Under SEEG | NCT07082101

Studies
Temporal Interference for Temporal Lobe Epilepsy Under SEEG

NCT07082101

Sponsor

Xijing Hospital

Status

Not yet recruiting

Last Update Posted

Jul 24, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Epilepsy

Interventions

temporal interference

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2025Estimated

Primary Completion Date

Jul 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Jun 29, 2025

First Submission Date that Met QC Criteria

Jul 22, 2025

First Posted Date

Jul 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2025

Last Update Posted Date

Jul 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Temporal interference	Experimental		Other: temporal interference

Interventions

Name	Type	Description	Arm Group Labels	Other Names
temporal interference	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of interictal electrophysiological biomaker changes in epilepsy	Electrophysiological biomarkers changes recorded by SEEG through the experiment.	24 hours after TI stimulation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen Jiang	Contact	+86-02984773664		jiangwen@fmmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital		Xi'an	Shaanxi	710032	China

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided