Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

NCT06667232 | Recruiting

• 1 other identifier: 2024-173-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Keywords

burst stimulation patterns; epilepsy; SEEG

Outcome Measures

Primary Outcomes (3)

• Modulation Factor

  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

  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

  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)

Study Arms (4)

Single-pulse stimulation

EXPERIMENTAL

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

Paired-pulse stimulation

EXPERIMENTAL

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

Stepwise frequency stimulation

EXPERIMENTAL

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

Other: Stepwise frequency stimulation

Burst stimulation

EXPERIMENTAL

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

Interventions

Single-pulse stimulation OTHER

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

Single-pulse stimulation

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.

Paired-pulse stimulation

Stepwise frequency stimulation OTHER

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

Stepwise frequency stimulation

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

Burst stimulation

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Liankun Ren, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

+86 13681576621; renlk2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 31, 2024
• Study Start: January 18, 2025
• Primary Completion: December 25, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)