PatiEnt Neuropsychological outcomeS After laseR Ablation

Completed

• Conditions: Cognitive Change

• Registration Number: NCT05075850
• Lead Sponsor: Monteris Medical

Brief Summary

PatiEnt Neuropsychological outcomeS After laseR ablation

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 Timeline

• Study First Submitted: 2021-09-15
• Study Start: 2021-09-29
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Results First Submitted: 2024-09-27
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Results First Posted: 2025-04-06
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Site-determined Cognitive Changes Per Domain	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

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

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States