Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

NCT ID: NCT06464653

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-12-30

Brief Summary

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of pallidothalamic tracts as adjunctive therapy for alleviating symptoms in Lennox-Gastaut Syndrome.

Detailed Description

This project aims to include 5 participants, and evaluate the effectiveness and safety of pallidothalamic tracts stimulation in patients with Lennox-Gastaut Syndrome through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with Lennox-Gastaut Syndrome with alternative treatment options.

Conditions

Lennox Gastaut Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pallidothalamic Tracts-DBS group

participants will undergo Pallidothalamic Tracts-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.

Group Type: EXPERIMENTAL

Forel's Field H-DBS ON

Intervention Type: DEVICE

The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy. The targets used in this study is Forel's Field H. 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.

Interventions

Forel's Field H-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 is Forel's Field H. 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Meets the diagnostic criteria for Lennox-Gastaut Syndrome (LGS) based on comprehensive assessment of medical history, seizure semiology, and electroencephalographic (EEG) findings during both ictal and interictal periods;

2. Interictal EEG demonstrates generalized paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) complexes;

3. Generalized tonic-clonic seizures (GTCs) have been captured in prior video-EEG monitoring, or seizure episodes have been clearly described by reliable eyewitnesses;

4. During the screening or baseline period, the following conditions are met:

1. The patient or caregiver is capable of reliably maintaining a seizure diary;

2. The seizure diary indicates an average of at least 5 seizures per month;

3. The patient is on two or more antiepileptic drugs (AEDs), with a stable treatment regimen (no new add-on or withdrawal of AEDs, excluding temporary rescue medications such as benzodiazepines; dose adjustments are allowed);

5. The patient has been evaluated through a comprehensive presurgical epilepsy workup and is considered unsuitable for, or has declined, resective epilepsy surgery, or has had unsatisfactory outcomes from resective or ablative procedures;

6. Providation of written informed consent, demonstrates adequate compliance with the study protocol, and agrees to participate in this clinical study.

Exclusion Criteria

1. Unable to provide a reliable seizure diary by self or legal guardian;

2. Predominant seizure type is focal impaired awareness seizures;

3. Psychogenic non-epileptic seizures within 12 months;

4. Brain structual abnormalities precluding safe implantation of deep brain stimulator;

5. Conditions associated with increased risk of intraoperative or postoperative bleeding (e.g., coagulopathy), or requirement for long-term oral anticoagulant or antiplatelet therapy;

6. Presence of other severe somatic or internal medical conditions, including significant hepatic or renal dysfunction;

7. Pregnant, or planning to pregnant within 2 years.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liankun_Ren

OTHER

Sponsor Role: lead

Responsible Party

Liankun_Ren

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Liankun Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2024-128-003

Identifier Type: -

Identifier Source: org_study_id