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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy, Drug Resistant
• Intervention / Treatment: Device: Subiculum-DBS ON

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Xuanwu Hospital,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: bilateral subiculum-DBS group; participants will undergo bilateral subiculum-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.

Device: Subiculum-DBS ON; The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are biliteral subiculum.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure frequency (SF28)	Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in open-label phase is defined as SF28 per month during the open-label period. Percent change in seizure frequency=100*(open-label SF28-baseline SF28)/baseline SF28.	Up to 1 year after subculum-DBS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure Responder Rate	The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.	Up to 1 year after subculum-DBS
Life quality evaluation	Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.	Up to 1 year after subculum-DBS
Cognitive function evaluation (MMSE)	Percentage change from baseline in Mini-Mental State Examination (MMSE) score.	Up to 1 year after subculum-DBS
Cognitive function evaluation (MoCA)	Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score.	Up to 1 year after subculum-DBS
Adverse Events	Rate of adverse events which were judged to be study-related throughout the study.	Up to 1 year after subculum-DBS
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)	The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.	Up to 1 year after subculum-DBS

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Liankun Ren, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): October 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; neuromodulation; Drug Resistant Epilepsy; Subiculum; Temporal lobe epilepsy with bilateral hippocampal sclerosis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 2024-112-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No