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

NCT07790224 | Not Yet Recruiting

• 1 other identifier: SBNK-YJ-2026-013-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Change From Pre-stimulation Baseline in SEEG Power Spectral Density

  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 Outcomes (1)

• Change in Cortical-Cortical Evoked Potential (CCEP) Amplitude Following TI Stimulation

  On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before and immediately after each 90-second TI stimulation condition.

Study Arms (1)

Multi-Parameter Temporal Interference Stimulation

EXPERIMENTAL

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

Interventions

Temporal Interference Stimulation DEVICE

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.

Multi-Parameter Temporal Interference Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Beijing Sanbo Brain Hospital

Beijing, Beijing Municipality, 100018, China

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jian Zhou

CONTACT

+86（10）85130669; zhoujian5151@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Model Details: All participants are assigned to a single study arm and receive multiple temporal interference stimulation conditions in a within-participant design. For each selected deep brain target, multiple stimulation frequencies are administered in a randomized order, with SEEG activity recorded before, during, and after each stimulation condition.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 27, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)