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Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome | Clinical Trials | Clareo Health

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Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

The Efficacy and Safety of Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome: A Prospective, Pilot Trial

NCT06464653•Liankun_Ren

View on ClinicalTrials.gov

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.

Eligibility

Age

14 - 35 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 1, 2024

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2025

Last Updated

July 30, 2025

Enrollment

ESTIMATED participants

Conditions

Lennox Gastaut Syndrome

Interventions

Forel's Field H-DBS ON

DEVICE

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

NCT05066217

Lennox Gastaut Syndrome

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RNS System LGS Feasibility Study

NCT05339126

EpilepsyLennox Gastaut Syndrome+3 more

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

Inclusion Criteria

Exclusion Criteria

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

RNS System LGS Feasibility Study

A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

Intermediate-Size Expanded Access Protocol (EAP) for LP352

Long-term Cardiac Monitoring in Epilepsy