Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)

Last updated: November 16, 2025
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Epilepsy

Seizure Disorders

Scar Tissue

Treatment

Subiculum-DBS ON

Clinical Study ID

NCT06436547
2024-112-002
  • Ages 14-65
  • All Genders

Study Summary

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

Eligibility Criteria

Inclusion

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 onceor more in recent 1 month.

  • After comprehensive preoperative evaluation, patients who are considered unsuitablefor or refuse resection surgery, or those for whom the effects of epileptic focusresection and thermocoagulation surgery are not satisfactory.

  • Participants must have had a non-invasive video-EEG monitoring revealing seizuresemiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy

  • Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesialsignal on T2 imaging

  • Informed consent signed.

Exclusion

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 anymetallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagalnerve stimulators are allowed if the parameter remains stable for at least 3 monthsprior to the screening visit;

  • Risk factors that would put the participant at risk for intraoperative orpostoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need forchronic anticoagulation or antiplatelet aggregation medications;

  • IQ < 55 or severe cognitive dysfunction, unable to complete the study;

  • Diagnosed with a progressive neurological disorder (including progressiveRasmussen'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 orself-injurious tendencies), schizophrenia, or neurodegenerative disorders;

  • Diagnosed with other serious physical disorders, internal diseases or severeabnormalities 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.

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Subiculum-DBS ON
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
March 30, 2026

Study Description

This project aims to include 6 participants, and evaluate the effectiveness and safety of bilateral hippocampal subcortical stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.

Connect with a study center

  • Xuanwu Hospital,Capital Medical University

    Beijing, Beijing 100053
    China

    Site Not Available

  • Xuanwu Hospital,Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100053
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.