Active — Not RecruitingNot Applicable

Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

China5 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range14 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

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.

What they're measuring

Seizure Frequency (SF28)

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

Trial details

NCT IDNCT06464653

SponsorLiankun_Ren

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Lennox Gastaut Syndrome trials