Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

Capital Medical University

Status: Enrolling

Conditions: Epilepsy

Treatments: Other: Paired-pulse stimulation; Other: Stepwise frequency stimulation; Other: Burst stimulation; Other: Single-pulse stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06667232

2024-173-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Single-pulse stimulation

Experimental group

Description:

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.

Treatment:

Other: Single-pulse stimulation

Paired-pulse stimulation

Experimental group

Description:

Paired-pulse stimulation paradigm associates a conditioning and a test stimulation to induce intracortical inhibition or facilitation by modifying the response amplitude.

Treatment:

Other: Paired-pulse stimulation

Stepwise frequency stimulation

Experimental group

Description:

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

Treatment:

Other: Stepwise frequency stimulation

Burst stimulation

Experimental group

Description:

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.

Treatment:

Other: Burst stimulation