RecruitingNot ApplicableNCT06708143
Temporal Interference for Drug Resistant Epilepsy
Noninvasive Temporal Interference Stimulation for the Treatment of Drug Resistant Epilepsy
Sponsor
Xuanwu Hospital, Beijing
Enrollment
30 participants
Start Date
Nov 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.
Eligibility
Min Age: 6 YearsMax Age: 60 Years
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
OTHERTemporal Interference
Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06708143
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