Evaluating Modulation Effects of Temporal Interference 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: Temporal Interference.
- Who it may be relevant to
- Registry conditions: Deep Brain Stimulation, Drug Resistant 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
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.
Detailed description
Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.
Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.
This study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation.
Interventions
- Other Temporal Interference
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.
Primary outcome measures
- Electrophysiological changes [Time frame: During the trial(up to 3 hours for each subject)]
Secondary outcome measures (1)
- Patient's subjective feelings and symptoms [Time frame: During the trial(up to 3 hours for each subject)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
China · 1 center
- Xuanwu Hospital,Capital Medical University — Beijing
Identifiers
NCT: NCT06663969 · 2024-258-002