Trial Outcomes & Findings for PatiEnt Neuropsychological outcomeS After laseR Ablation (NCT NCT05075850)

Last Updated: 2025-04-06

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

81 participants

Primary outcome timeframe

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.

Results posted on

2025-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	PENSAR Subjects All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing.
Overall Study STARTED	81
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	PENSAR Subjects All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing.
Overall Study Did not completed follow-up questionnaires	34

Baseline Characteristics

PatiEnt Neuropsychological outcomeS After laseR Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PENSAR Subjects n=47 Participants All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing.
Age, Customized Age	38.1 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PENSAR Subjects Baseline n=47 Participants All eligible study subjects who underwent LITT with the NeuroBlate System and completed Baseline study related testing	PENSAR Subjects Follow-Up n=47 Participants All eligible study subjects who underwent LITT with the NeuroBlate System and completed Follow-Up study related testing
Site-determined Cognitive Changes Per Domain Boston Naming (range 13-60. Higher score is better)	49 Score Standard Deviation 9.7	50.7 Score Standard Deviation 6.6
Site-determined Cognitive Changes Per Domain Trails Making (range 16-291. Higher value is worse)	32.9 Score Standard Deviation 15.4	35.3 Score Standard Deviation 27.7
Site-determined Cognitive Changes Per Domain Brief Visuospacial Memory Test (range 0-33. Higher score is better)	20.1 Score Standard Deviation 7.3	18.8 Score Standard Deviation 8.3
Site-determined Cognitive Changes Per Domain Animal Fluency (range 7-30. Higher score is better)	16.9 Score Standard Deviation 4.4	15.5 Score Standard Deviation 5.6
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	14.6 Score Standard Deviation 9.8
Site-determined Cognitive Changes Per Domain Logical Memory (range 0-32. Higher score is better)	22.3 Score Standard Deviation 6.0	18.9 Score Standard Deviation 6.5
Site-determined Cognitive Changes Per Domain Grooved Pegboard (Range 49-243. Lower score is better)	78.0 Score Standard Deviation 20.7	77.2 Score Standard Deviation 19.1

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	PENSAR Subjects Baseline n=47 Participants All eligible study subjects who underwent LITT with the NeuroBlate System and completed Baseline study related testing	PENSAR Subjects Follow-Up All eligible study subjects who underwent LITT with the NeuroBlate System and completed Follow-Up study related testing
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	—
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	—
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	—
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	—
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	—
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	—
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	—

Adverse Events

PENSAR Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christa Seligman

Monteris Medical

Phone: (952) 463-7747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place