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NCT Number: NCT06663969

Evaluating Modulation Effects of Temporal Interference Using SEEG

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.

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Liankun Ren, MD

CONTACT

[email protected]

+86 13681576621

Liankun Ren, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temporal Interference

Other

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 outcomes

  1. Electrophysiological changes

    Time frame: During the trial(up to 3 hours for each subject)

    Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.

Secondary outcomes

  1. Patient's subjective feelings and symptoms

    Time frame: During the trial(up to 3 hours for each subject)

    Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response.

Study contacts

Contact information is provided by the study sponsor or research team.

Liankun Ren, MD

CONTACT

[email protected]

+86 13681576621

Ren, MD

CONTACT

[email protected]

+86 13681576621

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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