Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

NCT06464653 | Active Not Recruiting DMC

• 1 other identifier: 2024-128-003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lennox Gastaut Syndrome

Keywords

Deep Brain Stimulation; Lennox-Gastaut Syndrome; Pallidothalamic Tracts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Seizure Responder Rate

  Up to 1 year after Forel's Field H-DBS

• Life quality evaluation

  Up to 1 year after Forel's Field H-DBS

• Cognitive function evaluation (MMSE)

  Up to 1 year after Forel's Field H-DBS

• Cognitive function evaluation (MoCA)

  Up to 1 year after Forel's Field H-DBS

• Adverse Events

  Up to 1 year after Pallidothalamic Tracts-DBS

Study Arms (1)

Pallidothalamic Tracts-DBS group

EXPERIMENTAL

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

Interventions

Forel's Field H-DBS ON 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.

Pallidothalamic Tracts-DBS group

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• Interictal EEG demonstrates generalized paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) complexes;
• Generalized tonic-clonic seizures (GTCs) have been captured in prior video-EEG monitoring, or seizure episodes have been clearly described by reliable eyewitnesses;
• During the screening or baseline period, the following conditions are met:
• The patient or caregiver is capable of reliably maintaining a seizure diary;
• The seizure diary indicates an average of at least 5 seizures per month;
• 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);
• 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;
• Providation of written informed consent, demonstrates adequate compliance with the study protocol, and agrees to participate in this clinical study.

You may not qualify if:

• Unable to provide a reliable seizure diary by self or legal guardian;
• Predominant seizure type is focal impaired awareness seizures;
• Psychogenic non-epileptic seizures within 12 months;
• Brain structual abnormalities precluding safe implantation of deep brain stimulator;
• Conditions associated with increased risk of intraoperative or postoperative bleeding (e.g., coagulopathy), or requirement for long-term oral anticoagulant or antiplatelet therapy;
• Presence of other severe somatic or internal medical conditions, including significant hepatic or renal dysfunction;
• Pregnant, or planning to pregnant within 2 years.

Sponsors & Collaborators

• Liankun_Ren: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Lennox Gastaut Syndrome

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Liankun Ren, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)