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Temporal Interference for Drug Resistant Epilepsy | Clinical Trials | Clareo Health

RECRUITINGNA

Temporal Interference for Drug Resistant Epilepsy

Noninvasive Temporal Interference Stimulation for the Treatment of Drug Resistant Epilepsy

NCT06708143•Xuanwu Hospital, Beijing

Summary

This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.

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. This study aims to investigate the treatment efficacy of TI deep brain stimulation by including drug-resistant patients aged 6-60. During and after TI stimulation, clinical and electrophysiology data will be recorded. Clinical, imaging and electrophysiology data will be analyzed and processed to advance the treatment of drug-resistant epilepsy.

Eligibility

Age

6 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are between the ages of 6 -60 years of age.
•Patients must be clinically evaluated as having drug resistant epilepsy.
•Persistence of disabling seizures at least 2 times per months or greater.
•Informed consent signed.

Exclusion Criteria

•Psychogenic non-epileptic seizures within 12 months;
•Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
•Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications; IQ \< 55 or severe cognitive dysfunction, unable to complete the study; Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
•Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
•Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; Pregnant, or planning to pregnant within 2 years; Participation in another clinical study within 3 months; Not suitable for enrollment as assessed by the multidisciplinary team of the center.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 30, 2024

Primary Completion Date

November 30, 2028

Completion Date

November 30, 2028

Last Updated

November 27, 2024

Enrollment

ESTIMATED participants

Conditions

Drug Resistant Epilepsy

Interventions

Temporal Interference

OTHER

Contacts

Liankun Ren, MD

CONTACT

+86 13681576621 renlk2022@outlook.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Temporal Interference for Drug Resistant Epilepsy

Inclusion Criteria

Exclusion Criteria

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