Parkinson DiseaseNCT05025254
Cognitive Testing Online in Parkinson's Disease
An observational study of Parkinson Disease, run by McGill University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neurocognitive testing
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with and without Parkinson's disease
Who may be able to join
- diagnosis of Parkinson's disease by neurologist or healthy individual with no diagnosis of any neurological illness
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3A 2B4
Madeleine Sharp, madeleine.sharp@mcgill.ca
About this study
Official title: 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:
- To establish the feasibility of performing large-scale deep cognitive phenotyping using online cognitive testing.
- 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
- Being tested
- Neurocognitive testing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Neurocognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of cognitive test set (feasibility)
Proportion of registered participants who complete all the cognitive testing.
Measured: 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)
Intraclass correlation coefficient for web-based vs. in-person performance on the n-back test will be computed
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madeleine Sharp, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025254
- Sponsor's protocol ID
- 2020-6045
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Cognitive Endophenotyping of Parkinson's Disease: A Platform Development and Pilot Study
- ClinicalTrials.gov ID
- NCT05025254
- Acronym / sponsor ID
- 2020-6045
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish the feasibility of performing large-scale deep cognitive phenotyping using online cognitive testing.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | Other: Neurocognitive testingThis is an observational study. The PD patient group will consist of participants who self-report that they have a diagnosis of Parkinson's disease |
| Healthy controls | – | Other: Neurocognitive testingThis 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 |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with and without Parkinson's disease
Key inclusion criteria (1 listed)
- diagnosis of Parkinson's disease by neurologist or healthy individual with no diagnosis of any neurological illness
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive testingWe 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. | Other | Healthy controls, PD patients |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madeleine Sharp, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine Sharp, MD (514-398-5174, madeleine.sharp@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.