NCT06524479

Brief Summary

This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jul 2024Oct 2027

Study Start

First participant enrolled

July 8, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2027

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

July 23, 2024

Last Update Submit

June 24, 2025

Conditions

Refractory EpilepsySleep

Keywords

homeostatic sleep pressuresynaptic plasticity

Outcome Measures

Primary Outcomes (1)

  • SEEG recordings with SPES during daytime and sleeptime

    Single-pulse electrical stimulation (SPES) serves as an effective dynamic marker for mapping functional brain connectivity. The stimulation parameters were set at 0.05 Hz, single biphasic pulses, 90 μs per phase, 4 mA.

    48 hours

Secondary Outcomes (6)

  • Dynamic melatonin levels

    48 hours

  • Dynamic cortisone levels

    48 hours

  • Dynamic 11-Deoxycortisol levels

    48 hours

  • Dynamic 21-Deoxycortisol levels

    48 hours

  • Dynamic 18-Hydroxycortisol levels

    48 hours

  • +1 more secondary outcomes

Study Arms (1)

SEEG recordings and SPES effects

EXPERIMENTAL

Single-pulse electrical stimulation (SPES) evokes transient neuronal responses that propagate through functional networks, providing a powerful tool to map brain connectivity. When delivered at low frequencies (0.05 Hz, every 20 s), SPES allows quantitative assessment of dynamic network interactions while avoiding long-term synaptic modifications. These stimulation-induced responses, recorded via stereoelectroencephalography (SEEG), reveal both local and distributed neural activity with millisecond precision.

Procedure: SEEG recordings and SPES

Interventions

SEEG recordings and SPESPROCEDURE

This study will utilize stereoelectroencephalography (SEEG) recordings combined with single-pulse electrical stimulation (SPES) to investigate functional brain connectivity and cortical excitability patterns in patients with epilepsy during both wakefulness and sleep states. The SEEG recordings will provide high-resolution intracranial electrophysiological data, while SPES will be employed to actively probe and quantify cortico-cortical connections. This combined approach will enable characterization of state-dependent neural network dynamics.

SEEG recordings and SPES effects

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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)
  • Subjects that experience surgical complications during the implant procedure will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

SpeA protein, Streptococcus pyogenes

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Liankun Ren, MD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

13681576621renlk2022@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2024

First Posted

July 29, 2024

Study Start

July 8, 2024

Primary Completion (Estimated)

June 7, 2026

Study Completion (Estimated)

October 8, 2027

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations

CN(1)