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Not yet recruiting NCT07710131

Neurocognitive Assessment CNSL and LGG

No phase Interventional PCNSL Brain Tumor Cognitive Dysfunction IDH Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Cognitive Assessment (TestMyBrain and Mobile Toolbox), Traditional Neuropsychological Testing, Quality of Life and Mood Questionnaires, Brain MRI (Standard of Care).
Who it may be relevant to
Registry conditions: PCNSL, Brain Tumor, Cognitive Dysfunction, IDH Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Evaluating the Construct Validity of Digital Cognitive Tests [Time frame: 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]
  • Assessing Test-Retest Reliability of the Digital Cognitive Tests Across Repeated Administrations and Different Environments. [Time frame: Baseline, 6 and 12 month follow ups]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07710131 · 25-759

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗