Cognitive Change
Conditions
Keywords
Quality of Life, Neuropsychological Test Scores, Visual Field
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.
Interventions
DEVICENeuroblate 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.
Sponsors
Monteris Medical
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PENSAR Subjects All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not completed follow-up questionnaires | 34 |
Baseline characteristics
| Characteristic | PENSAR Subjects |
|---|---|
| Age, Customized Age | 38.1 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
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).
Time frame: 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.
Population: Subjects who had LITT and completed baseline and follow-up testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PENSAR Subjects Baseline | Site-determined Cognitive Changes Per Domain | Wechsler Adult Intelligence Scale 3 Digital Span (range 2-58. Lower score is better) | 13.1 Score | Standard Deviation 6.1 |
| PENSAR Subjects Baseline | Site-determined Cognitive Changes Per Domain | Brief Visuospacial Memory Test (range 0-33. Higher score is better) | 20.1 Score | Standard Deviation 7.3 |
| PENSAR Subjects Baseline | Site-determined Cognitive Changes Per Domain | Trails Making (range 16-291. Higher value is worse) | 32.9 Score | Standard Deviation 15.4 |
| PENSAR Subjects Baseline | Site-determined Cognitive Changes Per Domain | Animal Fluency (range 7-30. Higher score is better) | 16.9 Score | Standard Deviation 4.4 |
| PENSAR Subjects Baseline | Site-determined Cognitive Changes Per Domain | Logical Memory (range 0-32. Higher score is better) | 22.3 Score | Standard Deviation 6 |
| PENSAR Subjects Baseline | Site-determined Cognitive Changes Per Domain | Grooved Pegboard (Range 49-243. Lower score is better) | 78.0 Score | Standard Deviation 20.7 |
| PENSAR Subjects Baseline | Site-determined Cognitive Changes Per Domain | Boston Naming (range 13-60. Higher score is better) | 49 Score | Standard Deviation 9.7 |
| PENSAR Subjects Follow-Up | Site-determined Cognitive Changes Per Domain | Grooved Pegboard (Range 49-243. Lower score is better) | 77.2 Score | Standard Deviation 19.1 |
| PENSAR Subjects Follow-Up | Site-determined Cognitive Changes Per Domain | Boston Naming (range 13-60. Higher score is better) | 50.7 Score | Standard Deviation 6.6 |
| PENSAR Subjects Follow-Up | Site-determined Cognitive Changes Per Domain | Trails Making (range 16-291. Higher value is worse) | 35.3 Score | Standard Deviation 27.7 |
| PENSAR Subjects Follow-Up | Site-determined Cognitive Changes Per Domain | Wechsler Adult Intelligence Scale 3 Digital Span (range 2-58. Lower score is better) | 14.6 Score | Standard Deviation 9.8 |
| PENSAR Subjects Follow-Up | Site-determined Cognitive Changes Per Domain | Logical Memory (range 0-32. Higher score is better) | 18.9 Score | Standard Deviation 6.5 |
| PENSAR Subjects Follow-Up | Site-determined Cognitive Changes Per Domain | Brief Visuospacial Memory Test (range 0-33. Higher score is better) | 18.8 Score | Standard Deviation 8.3 |
| PENSAR Subjects Follow-Up | Site-determined Cognitive Changes Per Domain | Animal Fluency (range 7-30. Higher score is better) | 15.5 Score | Standard Deviation 5.6 |
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.
Time frame: 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.
Population: Subjects who had LITT and completed baseline and follow-up testing
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PENSAR Subjects Baseline | Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests | Number of subjects who saw no change or improvement in Logical Memory Test | 19 Participants |
| PENSAR Subjects Baseline | Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests | Number of subjects who saw no change or improvement in Brief Visiospatial Memory Test | 29 Participants |
| PENSAR Subjects Baseline | Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests | Number of subjects who saw no change or improvement in Boston Naming Test | 25 Participants |
| PENSAR Subjects Baseline | Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests | Number of subjects who saw no change or improvement in Trails Making Test | 24 Participants |
| PENSAR Subjects Baseline | Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests | Number of subjects with no change or improvement in Wechsler Adult Intelligence 3 Digital Span Test | 30 Participants |
| PENSAR Subjects Baseline | Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests | Number of subjects who saw no change or improvement in Animal Fluency Test | 23 Participants |
| PENSAR Subjects Baseline | Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests | Number of subjects who saw no change or improvement in Grooved Pegboard Test | 29 Participants |