PatiEnt Neuropsychological outcomeS After laseR Ablation

NCT05075850 | Completed Results FDA Device

• 1 other identifier: PENSAR LAANTERN Registry
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 7

Brief Summary

PatiEnt Neuropsychological outcomeS After laseR ablation

Conditions

Cognitive Change

Keywords

Quality of Life; Neuropsychological Test Scores; Visual Field

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  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.

Interventions

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Monteris Medical: lead

Study Sites (7)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Advent Health Orlando

Orlando, Florida, 32804, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Norton Healthcare

Louisville, Kentucky, 40241, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Results Point of Contact

• Title: Christa Seligman
• Organization: Monteris Medical

cseligman@monteris.com

(952) 463-7747

Study Officials

• Patrick Landazuri, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 13, 2021
• Study Start: September 29, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-04

Locations

US (7)