Temporal Interference for Drug Resistant Epilepsy

Launched by XUANWU HOSPITAL, BEIJING · Nov 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called temporal interference (TI) for people aged 6 to 60 who have drug-resistant epilepsy. This means that their seizures do not respond to common medications and they experience disabling seizures at least twice a month. The goal of the study is to see if this treatment can help reduce their seizures and improve their quality of life.

To participate, individuals must be within the specified age range and have been diagnosed with drug-resistant epilepsy. However, some people may not be eligible, such as those with certain types of seizures that are not caused by epilepsy, those who have specific medical devices implanted in their bodies, or those with serious mental or physical health issues. Participants who join the study can expect to be closely monitored throughout the process, and they will need to provide informed consent to ensure they understand what the study involves. This trial is currently recruiting participants, and it aims to provide new hope for individuals struggling to manage their epilepsy.

Gender

ALL

Eligibility criteria

• 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.