Electrical stimulation of the subiculum for drug-resistant temporal lobe epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

  This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07680842

• Using sirolimus to treat drug-resistant focal epilepsy

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  Recruiting Early Phase 1 Xuanwu Hospital, Beijing · Beijing · NCT06719791

• Electrical stimulation of the subthalamic nucleus for drug-resistant focal motor epilepsy

  This study is testing if deep brain stimulation can help people with drug-resistant focal motor epilepsy have fewer seizures compared to those who receive a fake treatment.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT06248333

• Modified ketogenic diet for adults with drug-resistant epilepsy

  This study tests whether a modified ketogenic diet can help adults with drug-resistant epilepsy see fewer seizures and feel better overall.

  Recruiting Karolinska Institutet · Stockholm · NCT07878104

• iVEAcare Neuromodulation System for drug‑resistant epilepsy: a feasibility look

  This study tests whether the iVEAcare neuromodulation system is safe and can help reduce seizures and improve quality of life in people with drug‑resistant epilepsy.

  Recruiting at 7 sites iVEAcare · Herston, Queensland and 6 other locations · NCT07640191

• Real-world use of the OneRF Ablation System for epilepsy

  This registry collects real-world outcomes and device performance from patients with drug-resistant epilepsy who are treated with SEEG-guided RF ablation using the OneRF system.

  Recruiting at 3 sites NeuroOne Medical Technologies Corporation · Miami, Florida and 2 other locations · NCT07546253

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.