PatiEnt Neuropsychological outcomeS After laseR Ablation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-29

Study Completion Date

2023-09-30

Brief Summary

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PatiEnt Neuropsychological outcomeS After laseR ablation

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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.

Conditions

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Cognitive Change

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.