Neurocognitive Assessment CNSL and LGG

NCT07710131 | Not Yet Recruiting

• 1 other identifier: 25-759
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PCNSL; Brain Tumor; Cognitive Dysfunction; IDH Mutation; Low-grade Glioma

Keywords

Primary Central Nervous System Lymphoma (PCNSL); IDH-Mutant Low-Grade Glioma (LGG); Brain Tumors; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (3)

• Evaluating the Construct Validity of Digital Cognitive Tests

  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

  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.

  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

Study Arms (1)

Digital Cognitive Assessment

OTHER

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); Behavioral: Traditional Neuropsychological Testing; Other: Quality of Life and Mood Questionnaires; Other: Brain MRI (Standard of Care)

Interventions

Traditional Neuropsychological Testing BEHAVIORAL

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.

Digital Cognitive Assessment

Brain MRI (Standard of Care) OTHER

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.

Digital Cognitive Assessment

Quality of Life and Mood Questionnaires OTHER

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.

Digital Cognitive Assessment

Digital Cognitive Assessment (TestMyBrain and Mobile Toolbox) BEHAVIORAL

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.

Digital Cognitive Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

MeSH Terms

Conditions

Brain Neoplasms; Cognitive Dysfunction

Interventions

Quality of Life; Standard of Care

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lakshmi Nayak, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lakshmi Nayak, MD

CONTACT

617-632-2166; Lakshmi_Nayak@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu