PatiEnt Neuropsychological outcomeS After laseR Ablation (PENSAR)

PatiEnt Neuropsychological outcomeS After laseR ablation

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Device: Neuroblate System

Detailed Description

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 (Actual): 81

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • Florida
    • Orlando, Florida, United States, 32804
      • Advent Health Orlando
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
    • Louisville, Kentucky, United States, 40241
      • Norton Healthcare
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • University of Pittsburgh
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study is being conducted as a sub-study within the LAANTERN registry; therefore, all enrolled patients in PENSAR must be consented to both protocols.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 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.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.

Collaborators and Investigators

• Sponsor: Monteris Medical
• Investigators: Principal Investigator: Patrick Landazuri, MD, University of Kansas

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Visual Field; Neuropsychological Test Scores
• Other Study ID Numbers: PENSAR LAANTERN Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No