Cognitive Testing Online in Parkinson's Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Neurocognitive testing

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Madeleine Sharp, MD; Phone Number: 514-398-5174; Email: madeleine.sharp@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3A 2B4
      • Recruiting
      • McGill University Health Centre
      • Contact: Madeleine Sharp; Email: madeleine.sharp@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with and without Parkinson's disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PD patients; This is an observational study. The PD patient group will consist of participants who self-report that they have a diagnosis of Parkinson's disease	Other: Neurocognitive testing; 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.
Healthy controls; This is an observational study. The healthy control group will consist of participants who self-report that they do not have a diagnosis of Parkinson's disease	Other: Neurocognitive testing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate of cognitive test set (feasibility)	Proportion of registered participants who complete all the cognitive testing.	Measured once, as this is a cross-sectional study (time to complete cognitive tests is estimated to be 1.5 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of web-based vs in-person working memory testing (n-back test)	Intraclass correlation coefficient for web-based vs. in-person performance on the n-back test will be computed	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
Reliability of web-based vs in-person executive function testing (Stroop test performance)	Intraclass correlation coefficient for web-based vs. in-person performance on the Stroop test will be computed	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
Reliability of web-based vs in-person visuospatial function testing (Trail making test performance)	Intraclass correlation coefficient for web-based vs. in-person performance on the Trail making test will be computed	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
Reliability of web-based vs in-person declarative memory testing (recognition memory)	Intraclass correlation coefficient for web-based vs. in-person performance on the image recognition test will be computed	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
Reliability of web-based vs in-person reward processing testing	Intraclass correlation coefficient for web-based vs. in-person performance on the probabilistic reward task will be computed	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

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Madeleine Sharp, MD, McGill University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2026

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (ACTUAL): August 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2020-6045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No