## Protocol Section
### Identification Module
**NCT ID:** NCT06436547

**Brief Title:** Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)

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

#### Organization Study ID Info
**ID:** 2024-112-002
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xuanwu Hospital, Beijing

#### Responsible Party

**Investigator Affiliation:** Xuanwu Hospital, Beijing

**Investigator Full Name:** Liankun_Ren

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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

**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.

### Conditions Module

**Conditions:**

- Epilepsy, Drug Resistant

**Keywords:**

- Deep Brain Stimulation

- Drug Resistant Epilepsy

- Subiculum

- Temporal lobe epilepsy with bilateral hippocampal sclerosis

- neuromodulation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** participants will undergo 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.

**Intervention Names:**

- Device: Subiculum-DBS ON

**Label:** subiculum-DBS group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- subiculum-DBS group

**Description:** 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.

**Name:** Subiculum-DBS ON

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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 double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.

**Measure:** Seizure frequency (SF28)

**Time Frame:** Up to 1 year after subculum-DBS

#### Secondary Outcomes

**Description:** The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.

**Measure:** Seizure Responder Rate

**Time Frame:** Up to 1 year after subculum-DBS

**Description:** Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.

**Measure:** Life quality evaluation

**Time Frame:** Up to 1 year after subculum-DBS

**Description:** Percentage change from baseline in Mini-Mental State Examination (MMSE) score.

**Measure:** Cognitive function evaluation (MMSE)

**Time Frame:** Up to 1 year after subculum-DBS

**Description:** Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score.

**Measure:** Cognitive function evaluation (MoCA)

**Time Frame:** Up to 1 year after subculum-DBS

**Description:** Rate of adverse events which were judged to be study-related throughout the study.

**Measure:** Adverse Events

**Time Frame:** Up to 1 year after subculum-DBS

**Description:** The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.

**Measure:** Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)

**Time Frame:** Up to 1 year after subculum-DBS

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants are between the ages of 14 -65 years of age
* Refractory to anti-seizure medications (ASMs).
* 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.

**Maximum Age:** 65 Years

**Minimum Age:** 14 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** renlk2022@outlook.com

**Name:** Liankun Ren, MD

**Phone:** +86 13681576621

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** renlk2022@outlook.com

- **Name:** Liankun Ren, MD

- **Phone:** +86 13681576621

- **Role:** CONTACT

***Contact 2:***

- **Name:** Liankun Ren, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Xuanwu Hospital,Capital Medical University

**State:** Beijing

**Zip:** 100053

#### Overall Officials

**Official 1:**

**Affiliation:** Xuanwu Hospital, Beijing

**Name:** Liankun Ren, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000004828

- Term: Epilepsies, Partial

- ID: D000073376

- Term: Epileptic Syndromes

- ID: D000065703

- Term: Malformations of Cortical Development, Group I

- ID: D000054220

- Term: Malformations of Cortical Development

- ID: D000009421

- Term: Nervous System Malformations

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7983

- Name: Epilepsy

- Relevance: HIGH

- As Found: Epilepsy

- ID: M7989

- Name: Epilepsy, Temporal Lobe

- Relevance: HIGH

- As Found: Temporal Lobe Epilepsy

- ID: M2908

- Name: Hippocampal Sclerosis

- Relevance: HIGH

- As Found: Hippocampal Sclerosis

- ID: M369

- Name: Drug Resistant Epilepsy

- Relevance: HIGH

- As Found: Epilepsy, Drug Resistant

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7984

- Name: Epilepsies, Partial

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M1165

- Name: Epileptic Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M27589

- Name: Malformations of Cortical Development

- Relevance: LOW

- As Found: Unknown

- ID: M12365

- Name: Nervous System Malformations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004827

- Term: Epilepsy

- ID: D000004833

- Term: Epilepsy, Temporal Lobe

- ID: D000092223

- Term: Hippocampal Sclerosis

- ID: D000069279

- Term: Drug Resistant Epilepsy

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-31
