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

Sponsor
Beijing Sanbo Brain Hospital
Study ID
NCT07790224
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Aug 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

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. ]

Central Contacts

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