Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome
NCT ID: NCT05374824
Last Updated: 2024-07-16
Study Results
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Basic Information
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RECRUITING
4680 participants
OBSERVATIONAL
2022-04-01
2025-08-31
Brief Summary
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Lennox-Gastaut syndrome (LGS) has no cure. Although current treatments may help reduce the number of seizures, none are expected to eliminate them entirely; these treatments are palliative. The main treatments include anti-seizure medications and some surgical approaches, including the implantation of a vagus nerve stimulator (a pacemaker-like generator implanted in the chest wall and programmed by a physician to stimulate the vagus nerve in the neck) and corpus callosotomy (cutting through the band of fibers that connect the two sides of the brain). While both types of treatment (medications and surgeries) produce some benefit by reducing how often the seizures occur, both also have some risks. All medications can, in some patients, produce moderate to severe side effects. This is true of anti-seizure medications. Most patients with LGS take several anti-seizure medications at a time. Surgeries can also have associated risks and is additionally stressful for parents and family members. Currently, there is no strong evidence to support parents and physicians in deciding which type of treatment (more medicines or surgery) will be most successful for a child with LGS, and whether one or the other approach may lessen the toll that seizures take on a child's development and ability to function.
This study has two components. It will engage a network of seven pediatric hospitals in the United States where children with Lennox-Gastaut syndrome are cared for and determine whether seizure-related emergency department visits and hospitalizations are more likely to be reduced following the use of additional medications or adding palliative surgery to existing medications. The investigators will determine whether medical versus surgical treatment is more likely to lessen some of the developmental and functional difficulties that affect patients with LGS. The study will also determine whether starting therapies at a younger versus older age makes a difference.
The second component of the study will provide a description of the use of surgical versus medical treatment approaches across 18 pediatric hospitals in the United States (seven plus 11 centers). The investigators will describe how treatments differ across hospitals and over time.
The results from this study will help parents and providers make more informed choices about treatment for children with Lennox-Gastaut syndrome and will highlight areas for improvement in providing the best possible health care for this severe, lifelong disorder.
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Detailed Description
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Study Aims: Determine the comparative effectiveness of adding palliative surgery versus adding an LGS-approved medication (Aim 1a) for decreasing utilization of seizure-related emergency health care and (Aim 1b) for limiting the impairment of functional abilities. (Aim 2) Describe the frequency and patterns of utilization of the two therapy pathways at 18 PCORnet sites for variation over time and across sites as well as by patient features - age, medical fragility, race, ethnicity, and insurance type. In addressing these aims, the study will assess and improve PCORnet infrastructure and will enhance methods for future studies of LGS and other rare epilepsies.
Study Description: (Aim 1a) Observational retrospective cohort study of emergency health-care utilization and (Aim 1b) cross sectional study of the impact of treatment pathways on functional outcomes. (Aim 2) Retrospective open cohort study of frequency and patterns (by race, ethnicity, insurance, age) of utilization of the two treatment pathways.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
26 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Nationwide Children's Hospital
OTHER
University of Colorado, Denver
OTHER
University of Michigan
OTHER
University of Pittsburgh
OTHER
Seattle Children's Hospital
OTHER
St. Louis Children's Hospital
OTHER
University of Cincinnati
OTHER
Nemours Children's Health System
OTHER
Stanford University
OTHER
Monroe Carell Jr. Children's Hospital at Vanderbilt
OTHER
University of North Carolina
OTHER
Duke University
OTHER
Indiana University
OTHER
Johns Hopkins University
OTHER
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
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Sandi Lam
Chief, Division of Pediatric Neurosurgery
Principal Investigators
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Sandi Lam, MD MBA
Role: PRINCIPAL_INVESTIGATOR
Ann and Robert H. Lurie Children's Hospital of Chicago
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Nationwide Children's
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lam S, Rosenman M, Dixon-Salazar T, Knupp KG, Thio LL, Abel TJ, Welch WP, Reed L, Randle SC, Garcia-Sosa R, Hauptman JS, Foster CC, Alpern ER, Zhang L, Villalba N, Carroll M, Patel AD. Comparative effectiveness of epilepsy surgery versus additional anti-seizure medications for Lennox-Gastaut syndrome: study protocol for a multicenter, mixed-methods study. Front Neurol. 2025 Jun 18;16:1569551. doi: 10.3389/fneur.2025.1569551. eCollection 2025.
Related Links
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Other Identifiers
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RD-2020C2-20356
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2021-4532
Identifier Type: -
Identifier Source: org_study_id
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