Multi-Parameter Temporal Interference Stimulation in Patients With Epilepsy Undergoing SEEG Monitoring

August 24, 2026 updated by: Jian Zhou, Beijing Sanbo Brain Hospital

A Stereoelectroencephalography-Based Study of Brain Functional Modulation by Multi-Parameter Temporal Interference Stimulation in Patients With Epilepsy

This prospective exploratory interventional study aims to investigate the neurophysiological effects and safety of multi-parameter temporal interference (TI) stimulation in patients undergoing stereoelectroencephalography (SEEG) monitoring. Participants who have already undergone SEEG electrode implantation for clinical indications will receive non-invasive TI stimulation targeting selected deep brain regions according to their individual electrode coverage and neuroimaging data. Multiple stimulation frequencies will be tested while intracranial SEEG signals are recorded before, during, and after stimulation. The study will characterize frequency-dependent changes in local and distributed brain activity and explore the relationship between TI stimulation parameters and neurophysiological responses, providing in vivo evidence for parameter optimization of non-invasive deep brain stimulation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100018
        • Beijing Sanbo Brain Hospital
        • Contact:

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:

  • Aged 18 to 70 years, inclusive, with no restriction on sex.
  • Has undergone stereoelectroencephalography (SEEG) electrode implantation, with electrode contacts covering the target deep brain region(s), such as the thalamus, hippocampus, amygdala, or cingulate cortex.
  • Is in the postoperative SEEG monitoring period, is clinically stable, and is able to comply with the study procedures.
  • The participant or the participant's legally authorized representative is able to fully understand the purpose and procedures of the study and voluntarily provides written informed consent.

Exclusion Criteria:

  • Contraindications to magnetic resonance imaging (MRI), such as incompatible metallic implants or a cardiac pacemaker.
  • Psychiatric disorders or severe cognitive impairment.
  • Structural brain abnormalities, such as cerebral infarction, hydrocephalus, or severe thalamic atrophy.
  • Other severe neurological disorders that may interfere with participation in the study.
  • Medical or psychiatric contraindications, including recent myocardial infarction, cardiac arrhythmia, stroke, autonomic dysfunction, endocrine disorders, uncontrolled or difficult-to-control hypertension or hypotension, deep brain stimulation for other reasons, degenerative central nervous system disorders, or severe electrolyte disturbances.
  • Pregnancy or breastfeeding.
  • Participation in another drug or medical device clinical study within 3 months before screening.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-Parameter Temporal Interference Stimulation
Participants will receive multi-parameter temporal interference (TI) stimulation targeting one or two individualized deep brain regions selected according to SEEG electrode coverage and neuroimaging data. For each target, multiple stimulation frequencies will be administered in a randomized within-participant sequence, with SEEG activity recorded before, during, and after each stimulation condition. Repeated stimulation sequences and cortical-cortical evoked potential measurements will be performed to characterize the reproducibility and neurophysiological effects of TI stimulation.
Device: Temporal Interference Stimulation
Participants will receive individualized temporal interference (TI) stimulation targeting one or two deep brain regions selected according to SEEG electrode coverage and individual neuroimaging data. Scalp electrode placement and stimulation intensity will be optimized using individualized finite-element modeling. Multiple beat-frequency conditions corresponding to delta, theta, alpha, beta, gamma, and high-gamma frequency ranges will be administered in randomized order. SEEG activity will be recorded before, during, and after stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Pre-stimulation Baseline in SEEG Power Spectral Density
Time Frame: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before each TI stimulation condition, during the 90-second stimulation period, and immediately after completion of the stimulation condition.
On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before each TI stimulation condition, during the 90-second stimulation period, and immediately after completion of the stimulation condition.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Cortical-Cortical Evoked Potential (CCEP) Amplitude Following TI Stimulation
Time Frame: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before and immediately after each 90-second TI stimulation condition.
On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before and immediately after each 90-second TI stimulation condition.

Collaborators and Investigators

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

Sponsor

Beijing Sanbo Brain 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)

August 30, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 14, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBNK-YJ-2026-013-02

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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