Evaluating Modulation Effects of Temporal Interference Using SEEG
1 other identifier
interventional
20
1 country
1
Brief Summary
This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedStudy Start
First participant enrolled
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedFebruary 5, 2025
February 1, 2025
10 months
October 26, 2024
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electrophysiological changes
Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.
During the trial(up to 3 hours for each subject)
Secondary Outcomes (1)
Patient's subjective feelings and symptoms
During the trial(up to 3 hours for each subject)
Study Arms (1)
Temporal Interference
EXPERIMENTALThe investigators performed temporal interference (TI) stimulation to patients with drug-resistant epilepsy undergoing SEEG monitoring. They observed electrophysiological activity and clinical manifestations before, during, and after stimulation to investigate the electrophysiological mechanisms of TI.
Interventions
Researchers applied temporal interference (TI) stimulation to the deep brain nuclei of patients who had undergone SEEG monitoring, recording changes in electrical activity detected by SEEG.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of drug-resistant epilepsy;
- No severe systemic diseases;
- Implantation of stereotactic electrodes;
- Agreement to participate in this study and signs the informed consent form.
You may not qualify if:
- Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liankun Ren, MD
Xuanwu Hospital, Beijing
Central Study Contacts
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
October 26, 2024
First Posted
October 29, 2024
Study Start
November 4, 2024
Primary Completion
September 1, 2025
Study Completion
October 1, 2025
Last Updated
February 5, 2025
Record last verified: 2025-02