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NCT06436547Active, not recruiting

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

The Efficacy and Safety of Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Bilateral Hippocampal Sclerosis: A Prospective, Single-Arm Pilot Trial

Source: ClinicalTrials.gov · Last updated 19 Nov 2025

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
6 (estimated)
First submitted
24 May 2024
Start date
1 Jun 2024
Primary completion date
30 Oct 2025
Lead sponsor
Xuanwu Hospital, Beijing
Diseases
Epilepsy
NCT number
NCT06436547

What you commit to

  • Study type: Interventional
  • Planned participants: 6
  • From 1 Jun 2024 to the primary completion date, 30 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
  • Psychogenic non-epileptic seizures within 12 months;
  • 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;
  • 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;

Other

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

Who the study is looking for

  • 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.

Age in the registry: 14 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.