Cognitive ChangePENSARNCT05075850
PatiEnt Neuropsychological outcomeS After laseR Ablation
An observational study of Cognitive Change, run by Monteris Medical at 7 sites in United States.
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.
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
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.
- 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
Sponsor and investigators
- Lead sponsor
- Monteris Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Landazuri, MD, Principal investigator, University of Kansas
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
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
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.
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
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?
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.