Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.