Cognitive Testing Online in Parkinson's Disease

NCT05025254 | Recruiting

• 1 other identifier: 2020-6045
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 1.To establish the feasibility of performing large-scale deep cognitive phenotyping using online cognitive testing.
2. 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  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)

  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)

  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)

  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

  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

Study Arms (2)

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

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

Interventions

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.

Healthy controls; PD patients

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with and without Parkinson's disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3A 2B4, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Madeleine Sharp, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine Sharp, MD

CONTACT

514-398-5174; madeleine.sharp@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 27, 2021
• Study Start: August 1, 2021
• Primary Completion: September 1, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

CA (1)