Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome (PESL)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lennox Gastaut Syndrome
• Intervention / Treatment: Device: Forel's Field H-DBS ON

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• 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
• Accepts Healthy Volunteers: No

Description

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.

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: 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.

Device: 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.

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 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.	Up to 1 year after Forel's Field H-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 Forel's Field H-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 Forel's Field H-DBS
Life quality evaluation	Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome.	Up to 1 year after Forel's Field H-DBS
Cognitive function evaluation (MMSE)	Percentage change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE score ranges from 0 to 30, with higher scores representing better cognitive function and lower scores indicating greater cognitive impairment.	Up to 1 year after Forel's Field H-DBS
Cognitive function evaluation (MoCA)	Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting greater cognitive impairment.	Up to 1 year after Forel's Field H-DBS
Adverse Events	Rate of adverse events which were judged to be study-related throughout the study.	Up to 1 year after Pallidothalamic Tracts-DBS

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Lennox-Gastaut Syndrome; Pallidothalamic Tracts
• Additional Relevant MeSH Terms: Epileptic Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Epilepsy; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lennox Gastaut Syndrome
• Other Study ID Numbers: 2024-128-003

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
• product manufactured in and exported from the U.S.: No