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

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.

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.