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

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ClinicalTrials.gov Identifier: NCT05075850
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Study Description
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Brief Summary:
PatiEnt Neuropsychological outcomeS After laseR ablation

Condition or disease Intervention/treatment
Cognitive Change 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: PatiEnt Neuropsychological outcomeS After laseR Ablation
Actual Study Start Date : September 29, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Groups and Cohorts
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Intervention Details:
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. Site-determined cognitive changes per domain [ Time Frame: At least six months from baseline assessment ]
    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.


Secondary Outcome Measures :
  1. Change in raw test scores from standard battery of preferred neuropsychological tests [ Time Frame: At least six months from baseline assessment ]
    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.

  2. Incidence of visual field deficits in patients with MTLE [ Time Frame: At least six months from baseline assessment ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075850


Contacts
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Contact: Laura Menck 6127990288 lmenck@monteris.com

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Sorena Lo         
Principal Investigator: Viktoras Palys, MD         
United States, Florida
Advent Health Orlando Recruiting
Orlando, Florida, United States, 32804
Contact: Maritsa Casares         
Principal Investigator: James Baumgartner, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lauren Holland       lholland2@kumc.edu   
Principal Investigator: Patrick Landazuri, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ann Jerde         
Principal Investigator: Joseph Neimat, MD         
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40241
Contact: Avery Davenport       avery.davenport@nortonhealthcare.org   
Principal Investigator: Bradley Folley, PhD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Emily Harford         
Principal Investigator: Taylor Abel, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Madeleine Euckert         
Contact       madeleine.euckert@UTSouthwestern.edu   
Principal Investigator: Christian LoBue, PhD         
Sponsors and Collaborators
Monteris Medical
More Information
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Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT05075850    
Other Study ID Numbers: PENSAR LAANTERN Registry
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023

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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
Keywords provided by Monteris Medical:
Quality of Life
Neuropsychological Test Scores
Visual Field