Multicenter Sub-study for LAANTERN Registry NCT02392078 That Will Include Comprehensive Neuropsychological Assessment Data Collection

Study Overview
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Brief Summary
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PatiEnt Neuropsychological outcomeS After laseR ablation

Detailed Description
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This is a multicenter sub-study that will include comprehensive neuropsychological assessment data collection done at baseline (within 1 year prior to the index LITT procedure) and at follow-up (at least 6 months from the index LITT procedure). Visual field testing will be conducted in a subset of enrolled patients. Up to 250 subjects may be enrolled at up to 15 study sites.

Official Title
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PatiEnt Neuropsychological outcomeS After laseR Ablation

Conditions
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Cognitive Change

Intervention / Treatment
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* Device: Neuroblate System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent. Patient is enrolled in the LAANTERN trial and had an epilepsy diagnosis without the presence of a malignant brain tumor. Patient is 16 years of age or older. Patient has completed a baseline comprehensive neuropsychological assessment with a neuropsychologist. Exclusion Criteria: 1. Patient does not complete the index LITT procedure as specified in the LAANTERN registry.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neuroblate System|All subjects will undergo comprehensive neuropsychological assessment post-LITT per standard of care practice. Visual field testing will be conducted in a subset of enrolled patients.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Site-determined cognitive changes per domain | Neuropsychological test data will be collected for all study participants to describe cognitive domain specific changes as a cohort. Change will be assessed from raw test scores and demographically corrected standardized scores (where available). For this study, collected cognitive domains include Language, Executive Function, Attention, Verbal Memory, Visual Memory, Verbal Fluency, and Motor Function. | At least six months from baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in raw test scores from standard battery of preferred neuropsychological tests | Describe the observed change or stability of neuropsychological test scores in patients who underwent laser ablation surgery. Change will be assessed from raw test scores and demographically corrected standardized scores (where available). For this study, tests include Boston Naming, Trails making Test A and Test B, Digit Span, Logical memory test (subtest from Wechsler Memory Scale IV), BVMT--Brief Visuospatial Memory Test, Animal Fluency test, and Grooved Pegboard. | At least six months from baseline assessment | 
| Incidence of visual field deficits in patients with MTLE | Visual field testing using Humphry automated fields (HVF 24-2 SITA standard) will be conducted for a subset of patients to identify visual field deficits resulting after the LITT procedure. | At least six months from baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Neuropsychological Test Scores, Visual Field