Electrical stimulation of the subiculum for drug-resistant temporal lobe epilepsy
The Efficacy and Safety of Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Bilateral Hippocampal Sclerosis: A Prospective, Single-Arm Trial
This study is testing if deep brain stimulation can help people with drug-resistant temporal lobe epilepsy have fewer seizures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06436547 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of deep brain stimulation (DBS) targeting the subiculum as an adjunctive therapy for patients suffering from drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis. The study will enroll six participants and evaluate the impact of bilateral hippocampal subcortical stimulation on seizure frequency. It is designed as a prospective, interventional, unblinded, single-arm trial, aiming to provide new therapeutic options for patients who have not responded to traditional anti-seizure medications. Comprehensive preoperative evaluations will be conducted to ensure participant eligibility.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 65 who have refractory temporal lobe epilepsy with bilateral hippocampal sclerosis and have not responded to anti-seizure medications.
Not a fit: Patients with generalized or hereditary epilepsy, psychogenic non-epileptic seizures, or those with existing implanted electrical stimulation devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce seizure frequency and improve the quality of life for patients with drug-resistant epilepsy.
How similar studies have performed: While this approach is novel, similar studies involving deep brain stimulation for epilepsy have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants are between the ages of 14 -65 years of age * Refractory to anti-seizure medications (ASMs). * Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month. * After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory. * Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy * Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging * Informed consent signed. Exclusion Criteria: * Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations; * 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
- Xuanwu Hospital,Capital Medical University — Beijing, Beijing, 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.