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

ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Sanbo Brain Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Multi-Parameter Temporal Interference StimulationExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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