Multicenter Sub-study for LAANTERN Registry NCT02392078 That Will Include Comprehensive Neuropsychological Assessment Data Collection

Cognitive Change Clinical Trial

Official title:

PatiEnt Neuropsychological outcomeS After laseR Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05075850
• Other study ID #: PENSAR LAANTERN Registry
• Status: Completed
• Start date: September 29, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2023
• Source: Monteris Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

PatiEnt Neuropsychological outcomeS After laseR ablation

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Norton Healthcare	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Advent Health Orlando	Orlando	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Monteris Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Site-determined cognitive changes per domain	Neuropsychological test data will be collected for all study participants to 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, Executive Function, Attention, Verbal Memory, Visual Memory, Verbal Fluency, and Motor Function.	At least six months from baseline assessment
Secondary	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
Secondary	Incidence of visual field deficits in patients with MTLE	Visual field testing using Humphry automated fields (HVF 24-2 SITA standard) will be conducted for a subset of patients to identify visual field deficits resulting after the LITT procedure.	At least six months from baseline assessment