PatiEnt Neuropsychological outcomeS Aft… | Clinical Trial

Key information

Conditions

Cognitive Change

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Patient does not complete the index LITT procedure as specified in the LAANTERN registry.

Treatment and study plan

NeuroBlate System

Device

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.

Primary outcomes

Site-determined Cognitive Changes Per Domain

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.

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).

Secondary outcomes

Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests

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.

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.

Sponsors and collaborators

Lead sponsor

Monteris Medical

Industry

Registry information

Acronym: PENSAR

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Oct 13, 2021
Registry last updated: Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed