Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

NCT ID: NCT06667232

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-18

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Single-pulse stimulation

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Paired-pulse stimulation

Intervention Type 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

Stepwise frequency stimulation is a DES protocol that incrementally increases the stimulation frequency, starting from a lower to higher.

Group Type EXPERIMENTAL

Stepwise frequency stimulation

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Burst stimulation

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Single-pulse stimulation

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

Intervention Type 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.

Intervention Type OTHER

Stepwise frequency stimulation

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Liankun_Ren

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liankun Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Liankun Ren, MD

Role: CONTACT

+86 13681576621

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Liankun Ren, MD

Role: primary

+86 13681576621

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-173-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.