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Neurocognitive Assessment CNSL and LGG

13. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluating the Construct Validity of Digital Cognitive Tests
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dana-Farber Cancer Institute

Efterforskere

  • Ledende efterforsker: Lakshmi Nayak, MD, Dana-Farber Cancer Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-759

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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