PatiEnt Neuropsychological outcomeS After laseR Ablation

Monteris Medical81 enrolled

Overview

PatiEnt Neuropsychological outcomeS After laseR ablation

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cognitive Change

Interventions

Neuroblate SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient or legally authorized representative provides written authorization and/or consent. 2. Patient is enrolled in the LAANTERN trial and had an epilepsy diagnosis without the presence of a malignant brain tumor. 3. Patient is 16 years of age or older. 4. 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.

Locations (7)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Advent Health Orlando

Orlando, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Site-determined Cognitive Changes Per Domain

Neuropsychological test data collected will 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 (Boston Naming Test), Executive Function (Trails Making Test), Attention (Wechsler Adult Intelligence Scale 3 Digital Span Test), Verbal Memory (Logical Memory Test), Visual Memory (Brief Visiospacial Memory Test), Verbal Fluency (Animal Fluency Test), and Motor Function (Grooved Pegboard Test).

Time frame: At least six months from baseline assessment. Subjects were analyzed even if they only had 1 test performed. The baseline test information can still be used even if they didn't have follow up testing done.

Secondary Outcomes

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.

Time frame: At least six months from baseline assessment.Subjects were analyzed even if they only had 1 test performed. The baseline test information can still be used even if they didn't have follow up testing done.

Data from ClinicalTrials.gov

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