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Recruiting NCT06667232

Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single-pulse stimulation, Paired-pulse stimulation, Stepwise frequency stimulation, Burst stimulation.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 14 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Single-pulse stimulation
    Investigators use single-pulse electrical stimulations at 1Hz to elicit cortico-cortical evoked potentials
  • 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.
  • Other Stepwise frequency stimulation
    Stepwise incremental stimulation ranging from 5 Hz to 145 Hz following a cyclic pattern.
  • 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

Primary outcome measures

  • Modulation Factor [Time frame: 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)]
  • Phase Locking Value [Time frame: During the trial(up to 3 hours for each subject)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Xuanwu Hospital,Capital Medical University — Beijing

Identifiers

NCT: NCT06667232 · 2024-173-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗