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

Liankun_Ren

Status: Active, not recruiting

Conditions: Lennox Gastaut Syndrome

Treatments: Device: Forel's Field H-DBS ON

Study type: Interventional

Funder types: Other

Identifiers

NCT06464653

2024-128-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 14 to 35 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Pallidothalamic Tracts-DBS group

Experimental group

Description:

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.

Treatment:

Device: Forel's Field H-DBS ON