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NCT Number: NCT06667232

Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Liankun Ren, MD

CONTACT

[email protected]

+86 13681576621

Liankun Ren, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-pulse stimulation

Other

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

Paired-pulse stimulation

Other

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.

Stepwise frequency stimulation

Other

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

Burst stimulation

Other

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

Primary outcomes

  1. Modulation Factor

    Time frame: During 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)

  2. EEG power in spectral frequency bands

    Time frame: During 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)

  3. Phase Locking Value

    Time frame: During 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liankun Ren, MD

CONTACT

[email protected]

+86 13681576621

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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