Cognitive ChangePENSARNCT05075850

PatiEnt Neuropsychological outcomeS After laseR Ablation

An observational study of Cognitive Change, run by Monteris Medical at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

PatiEnt Neuropsychological outcomeS After laseR ablation Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Cognitive Change
What is being tested?: Neuroblate System
Type of treatment: Medical device
How many people: 81 participants
Where: 7 sitesUnited States
Study dates: 29 Sep 2021to 30 Sep 2023
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
Child, Adult, Older adult

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.

Who may be able to join

Patient or legally authorized representative provides written authorization and/or consent.
Patient is enrolled in the LAANTERN trial and had an epilepsy diagnosis without the presence of a malignant brain tumor.
Patient is 16 years of age or older.
Patient has completed a baseline comprehensive neuropsychological assessment with a neuropsychologist.

Who cannot join

1. Patient does not complete the index LITT procedure as specified in the LAANTERN registry.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Louisville
Louisville, Kentucky, 40202
Norton Healthcare
Louisville, Kentucky, 40241
Advent Health Orlando
Orlando, Florida, 32804
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

PatiEnt Neuropsychological outcomeS After laseR ablation

Read the 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.

Conditions: Cognitive Change
Being tested: Neuroblate System
Keywords: Quality of Life, Neuropsychological Test Scores, Visual Field

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuroblate SystemDevice
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.

Secondary outcomes (1)

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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 202130 Sep 2023

First posted13 Oct 2021
Study start29 Sep 2021
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cognitive ChangeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 81 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT05075850
Sponsor's protocol ID: PENSAR LAANTERN Registry
Acronym: PENSAR
Status last verified: Apr 2025
First submitted: 15 Sep 2021
Last updated: 6 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PatiEnt Neuropsychological outcomeS After laseR Ablation
ClinicalTrials.gov ID: NCT05075850
Acronym / sponsor ID: PENSAR / PENSAR LAANTERN Registry
Conditions: Cognitive Change
Keywords: Quality of Life, Neuropsychological Test Scores, Visual Field
Study type: Observational
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Monteris MedicalIndustry (pharma, biotech, devices)
Study start: 29 Sep 2021 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 13 Oct 2021 (actual)
Results: Posted 6 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PatiEnt Neuropsychological outcomeS After laseR ablation

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 5 Years

Who may qualify

Ages: 16 years and older
Sex: All
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

Patient or legally authorized representative provides written authorization and/or consent.
Patient is enrolled in the LAANTERN trial and had an epilepsy diagnosis without the presence of a malignant brain tumor.
Patient is 16 years of age or older.
Patient has completed a baseline comprehensive neuropsychological assessment with a neuropsychologist.

Key exclusion criteria (1 listed)

1. Patient does not complete the index LITT procedure as specified in the LAANTERN registry.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neuroblate SystemAll 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.	Device	–

Primary outcome

Site-determined Cognitive Changes Per Domain
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.
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).

1 secondary outcome

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

Results and safety

Results posted to the registry on 6 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PENSAR Subjects	81	47

Primary outcome: Site-determined Cognitive Changes Per Domain

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.. Mean (Standard Deviation). Unit: Score

Measure	PENSAR Subjects Baseline n = 47	PENSAR Subjects Follow-Up n = 47
Boston Naming (range 13-60. Higher score is better)	49 (9.7)	50.7 (6.6)
Trails Making (range 16-291. Higher value is worse)	32.9 (15.4)	35.3 (27.7)
Wechsler Adult Intelligence Scale 3 Digital Span (range 2-58. Lower score is better)	13.1 (6.1)	14.6 (9.8)
Logical Memory (range 0-32. Higher score is better)	22.3 (6.0)	18.9 (6.5)
Brief Visuospacial Memory Test (range 0-33. Higher score is better)	20.1 (7.3)	18.8 (8.3)
Animal Fluency (range 7-30. Higher score is better)	16.9 (4.4)	15.5 (5.6)
Grooved Pegboard (Range 49-243. Lower score is better)	78.0 (20.7)	77.2 (19.1)

Population analysed: Subjects who had LITT and completed baseline and follow-up testing.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline testing can occur any time prior to LITT. Follow-up testing occurs at least 6 months after LITT. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PENSAR Subjects	0 of 81 (0%)	0 of 81 (0%)	0 of 81

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Landazuri, MD principal investigator

University of Kansas

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Change, run by Monteris Medical at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Site-determined Cognitive Changes Per Domain (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.