Neurocognitive Assessment CNSL and LGG

July 13, 2026 updated by: Lakshmi Nayak, MD, Dana-Farber Cancer Institute

Neurocognitive Evaluation Using Digital Technology: A Pilot Study in Primary Central Nervous System Lymphoma and Low-grade Gliomas

This study is to determine whether self-administered digital cognitive tests can serve as accurate and reliable alternatives to established neuropsychological tests for evaluating cognitive functioning in participants with primary central nervous system lymphoma and low-grade gliomas.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, longitudinal, pilot study evaluating the validity and reliability of select digital cognitive tests compared to traditional neuropsychological measures in participants with newly diagnosed primary central nervous system lymphoma (PCNSL) and IDH-mutant low-grade gliomas (LGG).

Participants will complete both traditional paper-and-pencil neuropsychological tests and digital cognitive assessments at baseline, 6 months, and at post-treatment or 12-month follow-up, depending on diagnosis. Quality of life and mood will be assessed using the FACT-br and HADS questionnaires and Brain MRI (Magnetic Resonance Imaging). The study will evaluate validity, as well as test-retest reliability of digital cognitive tests, and explore associations between cognitive performance and neuroimaging outcomes.

It is expected about 36 people will participate in this research study within 12 months.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histopathologically confirmed newly diagnosed primary CNS diffuse large B-cell lymphoma (DLBCL) OR
  • Histopathologically confirmed IDH-M low grade glioma diagnosis in the past 12 months who have not started tumor directed therapy (if applicable).
  • Age ≥ 18 years.
  • Ability to consent to study.

Exclusion Criteria:

  • Patients who have severe visual impairment that cannot be corrected with glasses to read regular sized print.
  • Patients who have known psychiatric or substance abuse disorders that would interfere with their cooperation in completing the requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Digital Cognitive Assessment

Participants with newly diagnosed PCNSL or IDH-mutant LGG will undergo both traditional neuropsychological testing and digital cognitive assessments (TestMyBrain and Mobile Toolbox) at specified timepoints (baseline, 6 months, post-treatment or 12-14 months). Quality of life and mood questionnaires will also be administered. Brain MRI data will be collected as part of standard care. Participants will be sent a link to complete the digital cognitive tests at home. Questionnaires will also be sent via email to complete. Data will be collected from brain MRIs obtained as part of standard of care/routine surveillance.

  • Screening visit
  • Baseline visit (2- months)
  • Follow-Up visit (3-month)
  • End of Treatment 2 months after completing treatment (PCNSL only)
  • Final Assessment 12-14 months after baseline (LGG only).
  • Brain MRI (standard of care) based on participant permission

There is no follow-up care as part of this research study.
Behavioral: Digital Cognitive Assessment (TestMyBrain and Mobile Toolbox)
Participants will complete a battery of digital cognitive tests using the TestMyBrain and Mobile Toolbox platforms, assessing attention, processing speed, executive function, and memory. Assessments will be conducted in clinic and at home at multiple timepoints.
Behavioral: Traditional Neuropsychological Testing
Participants will complete standard paper-and-pencil neuropsychological tests, including WAIS-IV Digit Span, Brief Test of Attention, Symbol Digits Modalities Test, Trail Making Test Parts A and B, Stroop, and Hopkins Verbal Learning Test-Revised.
Other: Quality of Life and Mood Questionnaires
Participants will complete the Functional Assessment of Cancer Therapy - Brain (FACT-br) and Hospital Anxiety and Depression Scale (HADS) at baseline and follow-up timepoints.
Other: Brain MRI (Standard of Care)
Brain MRI data will be collected as part of routine clinical care to assess tumor response, stability, or progression, and correlated with cognitive test results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the Construct Validity of Digital Cognitive Tests
Time Frame: Baseline assessment only, conducted at study enrollment for each participant.
To evaluate the construct validity of digital cognitive tests by comparing domain-specific composite scores derived from traditional neuropsychological and digital cognitive measures of attention, processing speed, executive functioning, and memory. Baseline traditional and digital cognitive data will be collected from PCNSL patients (before chemotherapy) and LGG patients (post-resection). Traditional tests include WAIS-IV Digit Span, Brief Test of Attention, Symbol Digit Modalities Test, Trail Making Test A/B, Stroop, and HVLT-R. Digital platforms include TestMyBrain (Digit Span, Digit Symbol Matching, Trails A/B, Reaction Time, Verbal Paired Associates) and Mobile Toolbox (Arrow Matching, Sequences, Number-Symbol Match, Shape-Color Sorting, and Associative Memory). Moderate to strong correlations between traditional and digital composite domain-specific composite scores will be interpreted as having evidence of convergent validity.
Baseline assessment only, conducted at study enrollment for each participant.
Evaluating the Discriminant Validity of Digital Cognitive Tests with Emotional Wellbeing Measures
Time Frame: Baseline
To evaluate the discriminant validity of the digital cognitive tests in both cohorts ( PCNSL and LGG) by examining correlations between digital global composite indices of TestMyBrain and Mobile Toolbox tests with the emotional wellbeing subscale of the FACT-BR and the Hospital Anxiety and Depression scale. For low-grade glioma (LGG) patients, assessments will be conducted at baseline; for primary central nervous system lymphoma (PCNSL) patients, assessments will be conducted at baseline. Small magnitude correlations are expected to provide evidence of discriminant validity.
Baseline
Assessing Test-Retest Reliability of the Digital Cognitive Tests Across Repeated Administrations and Different Environments.
Time Frame: Baseline, 6 and 12 month follow ups
Test-retest reliability of the TestMyBrain and Mobile Toolbox cognitive tests will be evaluated in both cohorts (PCNSL and LGG) by examining correlations between baseline test scores of both groups and scores obtained at the 6-month and 12-month follow-up assessments. The baseline evaluation and 12-month evaluations will be completed in the clinic/hospital setting, and the 6-month follow-up digital cognitive tests will be completed at home. Correlations between baseline and 6-month scores will be used to evaluate the reliability of the digital cognitive measures across clinic-to-home testing environments. Correlations between baseline and 12-month scores will be used to evaluate the reliability of the digital cognitive measures across repeated assessments conducted in the same clinic/hospital environment.
Baseline, 6 and 12 month follow ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Lakshmi Nayak, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-759

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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