Non-invasive brain stimulation for drug-resistant epilepsy
Noninvasive Temporal Interference Stimulation for the Treatment of Drug Resistant Epilepsy
This study is testing a new non-invasive brain stimulation technique for people aged 6-60 with drug-resistant epilepsy to see if it can help control their seizures better than current treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 60 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06708143 on ClinicalTrials.gov |
What this trial studies
This prospective study investigates the efficacy of temporal interference (TI) as a non-invasive treatment for patients aged 6-60 with drug-resistant epilepsy. TI utilizes overlapping electric fields to stimulate targeted deep brain areas, potentially offering an alternative to traditional invasive deep brain stimulation. The study will collect clinical and electrophysiological data during and after TI stimulation to assess its effectiveness. By analyzing this data, the research aims to enhance treatment options for individuals suffering from this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 6-60 who have been diagnosed with drug-resistant epilepsy and experience disabling seizures at least twice a month.
Not a fit: Patients with psychogenic non-epileptic seizures, those with implanted electrical devices, or significant cognitive dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for patients with drug-resistant epilepsy.
How similar studies have performed: While the use of temporal interference is a novel approach, similar non-invasive brain stimulation techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Liankun Ren, MD — Xuanwu Hospital, Beijing
- Study coordinator: Liankun Ren, MD
- Email: renlk2022@outlook.com
- Phone: +86 13681576621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.