Epilepsy
Conditions
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.
Interventions
DEVICETemporal Interference Stimulation
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.
Sponsors
Beijing Sanbo Brain Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Contacts
CONTACTJian Zhou
Outcome results
None listed