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Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06667232
Enrollment
20
Registered
2024-10-31
Start date
2025-01-18
Completion date
2026-12-01
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

burst stimulation patterns, epilepsy, SEEG

Brief summary

The study aims to evaluate modulation effects of burst stimulation patterns via SEEG.

Detailed description

Our research group plans to conduct a study on patients with drug-resistant epilepsy who have SEEG electrodes implanted. The study will evaluate and compare the modulation effect of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation via direct electrical stimulation using SEEG. The goal is to explore the focal and network modulation effect of distinct stimulation paradigms during the resting state and post-seizure state.

Interventions

OTHERSingle-pulse stimulation

Investigators use single-pulse electrical stimulations at 1Hz to elicit cortico-cortical evoked potentials

OTHERPaired-pulse stimulation

The repetitive delivery of pairs of stimulation pulses is DES patten with a 5-50 ms interval between each pulse, constitutes repetitive paired-pulse stimulation.

OTHERStepwise frequency stimulation

Stepwise incremental stimulation ranging from 5 Hz to 145 Hz following a cyclic pattern.

Burst stimulation pattern consisting of short bursts delivered once a second and an intraburst frequency of 50 Hz, 100 Hz, 150 Hz, 175 Hz and 200 Hz

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Drug-resistant focal epilepsy * Justified SEEG exploration in the context of presurgical assessment of epilepsy * Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis * Written non-opposition to study participation

Exclusion criteria

* Pregnant women (Contraindication to SEEG exploration) * Psychiatric disorders * History of psychotic disorders * History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology * Subjects that experience surgical complications during the implant procedure will be excluded from the study

Design outcomes

Primary

MeasureTime frameDescription
Modulation FactorDuring the trial(up to 3 hours for each subject)Investigators calculate normalized the Modulation Factors of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation patterns using (stimulation-pre-stimulation)/(stimulation + pre-stimulation)
EEG power in spectral frequency bandsDuring the trial(up to 3 hours for each subject)Using SEEG-implanted electrodes, the investigators applied electrical stimulation single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods. EEG Frequency Bands delta (1-4 Hz) theta (5-8 Hz) alpha (9-12 Hz) beta (13-30 Hz) low gamma (31-70 Hz) high gamma (71-150 Hz)
Phase Locking ValueDuring the trial(up to 3 hours for each subject)To estimate functional connectivity through the oscillatory synchrony of two brain regions, phase locking value (PLV) provides a measure of inter-regional synchrony based on phase difference between the paired signals.

Countries

China

Contacts

Primary ContactLiankun Ren, MD
renlk2022@outlook.com+86 13681576621

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026