Temporal Interference for Drug Resistant Epilepsy

ConditionDrug 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Temporal Interference
Other intervention
Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Temporal InterferenceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Seizure Frequency (SF28)

Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3- month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.

Time frame