About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Temporal Interference Stimulation
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change From Pre-stimulation Baseline in SEEG Power Spectral Density
Secondary outcomes
Change in Cortical-Cortical Evoked Potential (CCEP) Amplitude Following TI Stimulation
Sponsors and contacts
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