Temporal Interference for Drug Resistant Epilepsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-60
SponsorXuanwu Hospital, Beijing

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Temporal Interference

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators