Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

Other illness

• 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;
• 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;

Other

• Brain structual abnormalities precluding safe implantation of deep brain stimulator;
• Pregnant, or planning to pregnant within 2 years.

• 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.