Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG
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 →
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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