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 range
14 Years – 35 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.