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NCT Number: NCT05025254

Cognitive Testing Online in Parkinson's Disease

This is a feasibility and pilot study. Though large-scale online neurocognitive testing is increasingly being done in psychiatry, there are no such efforts in Parkinson's research. Thus a large part of this pilot study will be to demonstrate feasibility and reliability, and use this experience to develop a feasible protocol for ongoing research. The specific short-term objectives are:

1. To establish the feasibility of performing large-scale deep cognitive phenotyping using online cognitive testing. 2. To demonstrate that online neurocognitive testing is valid and reliable in a smaller sample of locally recruited participants tested both in-lab and online.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Centre

Montreal, Quebec, H3A 2B4, Canada

Location status: Recruiting

Location contact

Madeleine Sharp

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of Parkinson's disease by neurologist or healthy individual with no diagnosis of any neurological illness

Exclusion criteria

  • Psychotic spectrum disorders, active uncontrolled depression, advanced dementia (i.e. needing assistance with daily activities such as dressing or bathing), major stroke, major head injury, epilepsy requiring anti-seizure medications

Treatment and study plan

Neurocognitive Testing

Other

We are assessing several cognitive domains and have made minor adaptations (reducing the total number of trials or lengthening response windows) to several standard neuropsychology tests including measures of executive function, working memory, visuospatial function, declarative memory, reward processing, response inhibition.

Overall, the tests we use follow a standard set-up: participants are shown stimuli on the screen and are asked to provide a response using either a keyboard or a mouse, based on a specific set of instructions. We always provide a detailed set of on-screen instructions and a practice phase. In some cases, information about performance is provided in the form of points, in other cases, none is provided.

Primary outcomes

  1. Completion rate of cognitive test set (feasibility)

    Time frame: Measured once, as this is a cross-sectional study (time to complete cognitive tests is estimated to be 1.5 hours)

    Proportion of registered participants who complete all the cognitive testing.

Secondary outcomes

  1. Reliability of web-based vs in-person working memory testing (n-back test)

    Time frame: Web-based and in-person testing will occur at two separate time points, at least 1 month apart and no more than 3 months apart

    Intraclass correlation coefficient for web-based vs. in-person performance on the n-back test will be computed

  2. Reliability of web-based vs in-person executive function testing (Stroop test performance)

    Time frame: Web-based and in-person testing will occur at two separate time points, at least 1 month apart and no more than 3 months apart

    Intraclass correlation coefficient for web-based vs. in-person performance on the Stroop test will be computed

  3. Reliability of web-based vs in-person visuospatial function testing (Trail making test performance)

    Time frame: Web-based and in-person testing will occur at two separate time points, at least 1 month apart and no more than 3 months apart

    Intraclass correlation coefficient for web-based vs. in-person performance on the Trail making test will be computed

  4. Reliability of web-based vs in-person declarative memory testing (recognition memory)

    Time frame: Web-based and in-person testing will occur at two separate time points, at least 1 month apart and no more than 3 months apart

    Intraclass correlation coefficient for web-based vs. in-person performance on the image recognition test will be computed

  5. Reliability of web-based vs in-person reward processing testing

    Time frame: Web-based and in-person testing will occur at two separate time points, at least 1 month apart and no more than 3 months apart

    Intraclass correlation coefficient for web-based vs. in-person performance on the probabilistic reward task will be computed

Study contacts

Contact information is provided by the study sponsor or research team.

Madeleine Sharp, MD

CONTACT

[email protected]

514-398-5174

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

Deep Cognitive Endophenotyping of Parkinson's Disease: A Platform Development and Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Aug 27, 2021
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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