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NCT Number: NCT07790224

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Sanbo Brain Hospital

Beijing, Beijing Municipality, 100018, China

Location contact

Jian Zhou

CONTACT

[email protected]

+86(10)85130669

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhou

CONTACT

[email protected]

+86(10)85130669

Sponsors and collaborators

Lead sponsor

Beijing Sanbo Brain Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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