Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

January 18, 2025 updated by: Liankun_Ren, Xuanwu Hospital, Beijing
The study aims to evaluate modulation effects of burst stimulation patterns via SEEG.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital,Capital Medical University
        • Contact:
        • Principal Investigator:
          • Liankun Ren, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-pulse stimulation
Single pulse electrical stimulation (SPES) is an investigational direct electrical stimulation (DES) pattern. Direct cortical stimulation applied at a frequency of ∼1Hz can probe cortico-cortical connections by averaging electrocorticogram time-lock to the stimuli.
Other: Single-pulse stimulation
Investigators use single-pulse electrical stimulations at 1Hz to elicit cortico-cortical evoked potentials
Experimental: Paired-pulse stimulation
Paired-pulse stimulation paradigm associates a conditioning and a test stimulation to induce intracortical inhibition or facilitation by modifying the response amplitude.
Other: Paired-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.
Experimental: Stepwise frequency stimulation
Stepwise frequency stimulation is a DES protocol that incrementally increases the stimulation frequency, starting from a lower to higher.
Other: Stepwise frequency stimulation
Stepwise incremental stimulation ranging from 5 Hz to 145 Hz following a cyclic pattern.
Experimental: Burst stimulation
Burst stimulation is a DES patterned repetitive stimulation method; it represents a "more precise" and "smarter" electrical stimulation paradigm. Within a group, high-frequency pulses are emitted, and between groups, low-frequency pulses are delivered. This pattern of pulse delivery more closely mimics the physiological activity of neurons within the brain.
Other: Burst stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the trial(up to 3 hours for each subject)
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)
During the trial(up to 3 hours for each subject)
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.
During the trial(up to 3 hours for each subject)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Liankun Ren, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2025

Primary Completion (Estimated)

December 25, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 27, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 18, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-173-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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