Cognitive Testing Online in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05025254
• Other study ID #: 2020-6045
• Status: Recruiting
• Start date: August 2021
• Est. completion date: December 2026

Study information

• Verified date: August 2021
• Source: McGill University
• Contact: Madeleine Sharp, MD
• Phone: 514-398-5174
• Email: madeleine.sharp[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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