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PatiEnt Neuropsychological outcomeS After laseR ablation
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient does not complete the index LITT procedure as specified in the LAANTERN registry.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Landazuri, MD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Advent Health Orlando |
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| ID | Title | Description |
|---|---|---|
| FG000 | PENSAR Subjects | All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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47 subjects completed baseline PENSAR study testing.
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| ID | Title | Description |
|---|---|---|
| BG000 | PENSAR Subjects | All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Subjects who had LITT and completed baseline and follow-up testing. | Posted | Mean | Standard Deviation | Score | 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. |
|
Baseline testing can occur any time prior to LITT. Follow-up testing occurs at least 6 months after LITT
No adverse events are collected for the PENSAR study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PENSAR Subjects | All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christa Seligman | Monteris Medical | (952) 463-7747 | cseligman@monteris.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2021 | Apr 4, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2021 | Apr 4, 2025 | SAP_002.pdf |
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| 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. |
| Orlando |
| Florida |
| 32804 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Norton Healthcare | Louisville | Kentucky | 40241 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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All eligible study subjects who underwent LITT with the NeuroBlate System and completed Baseline study related testing |
| OG001 | PENSAR Subjects Follow-Up | All eligible study subjects who underwent LITT with the NeuroBlate System and completed Follow-Up study related testing |
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| 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. | Subjects who had LITT and completed baseline and follow-up testing | Posted | Count of Participants | Participants | No | 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. |
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| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
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| Number of subjects with no change or improvement in Wechsler Adult Intelligence 3 Digital Span Test |
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| Number of subjects who saw no change or improvement in Logical Memory Test |
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| Number of subjects who saw no change or improvement in Brief Visiospatial Memory Test |
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| Number of subjects who saw no change or improvement in Animal Fluency Test |
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| Number of subjects who saw no change or improvement in Grooved Pegboard Test |
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