Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

Not Applicable

Active, not recruiting

• Conditions: Lennox Gastaut Syndrome

• Registration Number: NCT06464653
• Lead Sponsor: Liankun_Ren

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.

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-18
• Status Verified: 2024-12
• Last Update Submitted: 2025-07-27
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Seizure Frequency (SF28)	Up to 1 year after Forel's Field H-DBS	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to 1 year after Pallidothalamic Tracts-DBS	Rate of adverse events which were judged to be study-related throughout the study.
Life quality evaluation	Up to 1 year after Forel's Field H-DBS	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.
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)	Up to 1 year after Forel's Field H-DBS	The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.
Cognitive function evaluation (MMSE)	Up to 1 year after Forel's Field H-DBS	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.
Seizure Responder Rate	Up to 1 year after Forel's Field H-DBS	The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Cognitive function evaluation (MoCA)	Up to 1 year after Forel's Field H-DBS	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.

Trial Locations

Locations (1)

Xuanwu Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China