Clinical trial NCT05025254: Cognitive Testing Online in Parkinson's Disease
Official title: Deep Cognitive Endophenotyping of Parkinson's Disease: A Platform Development and Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with and without Parkinson's disease

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Completion rate of cognitive test set (feasibility)
timeFrame: Measured once, as this is a cross-sectional study (time to complete cognitive tests is estimated to be 1.5 hours)
Secondary outcomes:
measure: Reliability of web-based vs in-person working memory testing (n-back test)
timeFrame: 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
measure: Reliability of web-based vs in-person executive function testing (Stroop test performance)
timeFrame: 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
measure: Reliability of web-based vs in-person visuospatial function testing (Trail making test performance)
timeFrame: 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
measure: Reliability of web-based vs in-person declarative memory testing (recognition memory)
timeFrame: 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
measure: Reliability of web-based vs in-person reward processing testing
timeFrame: 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
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Madeleine Sharp, MD
role: PRINCIPAL_INVESTIGATOR
References: