NCT05075850: PENSAR

PatiEnt Neuropsychological outcomeS After laseR Ablation

Completed Results posted Last updated 6 April 2025

What this trial tests

trial testing Neuroblate System in Cognitive Change in 81 participants. Completed in 30 September 2023.

Timeline

29 September 2021

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	Monteris Medical
Status	Completed
Study type	OBSERVATIONAL
Enrollment	81
Start date	29 September 2021
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	7 locations across United States

Drugs / interventions tested

• Neuroblate System

Conditions studied

• Cognitive Change — all drugs for Cognitive Change →

Sponsor

Monteris Medical — full company profile →

Who can join

16 and older, any sex, with Cognitive Change. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Site-determined Cognitive Changes Per Domain Primary · 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).

Boston Naming (range 13-60. Higher score is better)

Group	Value	95% CI
PENSAR Subjects Baseline	49	± 9.7
PENSAR Subjects Follow-Up	50.7	± 6.6

Trails Making (range 16-291. Higher value is worse)

Group	Value	95% CI
PENSAR Subjects Baseline	32.9	± 15.4
PENSAR Subjects Follow-Up	35.3	± 27.7

Wechsler Adult Intelligence Scale 3 Digital Span (range 2-58. Lower score is better)

Group	Value	95% CI
PENSAR Subjects Baseline	13.1	± 6.1
PENSAR Subjects Follow-Up	14.6	± 9.8

Logical Memory (range 0-32. Higher score is better)

Group	Value	95% CI
PENSAR Subjects Baseline	22.3	± 6.0
PENSAR Subjects Follow-Up	18.9	± 6.5

Brief Visuospacial Memory Test (range 0-33. Higher score is better)

Group	Value	95% CI
PENSAR Subjects Baseline	20.1	± 7.3
PENSAR Subjects Follow-Up	18.8	± 8.3

Animal Fluency (range 7-30. Higher score is better)

Group	Value	95% CI
PENSAR Subjects Baseline	16.9	± 4.4
PENSAR Subjects Follow-Up	15.5	± 5.6

Grooved Pegboard (Range 49-243. Lower score is better)

Group	Value	95% CI
PENSAR Subjects Baseline	78.0	± 20.7
PENSAR Subjects Follow-Up	77.2	± 19.1

Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests Secondary · 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.

Number of subjects who saw no change or improvement in Boston Naming Test

Group	Value	95% CI
PENSAR Subjects	25

Number of subjects who saw no change or improvement in Trails Making Test

Group	Value	95% CI
PENSAR Subjects	24

Number of subjects with no change or improvement in Wechsler Adult Intelligence 3 Digital Span Test

Group	Value	95% CI
PENSAR Subjects	30

Number of subjects who saw no change or improvement in Logical Memory Test

Group	Value	95% CI
PENSAR Subjects	19

Number of subjects who saw no change or improvement in Brief Visiospatial Memory Test

Group	Value	95% CI
PENSAR Subjects	29

Number of subjects who saw no change or improvement in Animal Fluency Test

Group	Value	95% CI
PENSAR Subjects	23

Number of subjects who saw no change or improvement in Grooved Pegboard Test

Group	Value	95% CI
PENSAR Subjects	29

Sponsor's own description

PatiEnt Neuropsychological outcomeS After laseR ablation

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interstitial Thermal Therapy in Mesial Temporal Lobe Epilepsy.
   Landazuri P, Cheng JJ, Leuthardt E, Kim AH, et al · · 2025 · cited 4× · PMID 40622685 · DOI 10.1001/jamaneurol.2025.1897