Parkinson DiseaseNCT06217484
Investigation of Effects of Delayed Feedback on Non-motor Symptoms in Individuals With Parkinson's Disease
An observational study of Parkinson Disease, run by Kessler Foundation at 1 site in United States.
Trial summary
Learning deficits are frequent in individuals with Parkinson's Disease. Clear feedback is integral because through feedback individuals know whether they should stick with an action that they have been doing (if the feedback is positive), or change their course of action (if the feedback is negative). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- delayed feedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Parkinson Disease
Who may be able to join
- Only participants with scores above 24/30 on the Montreal Cognitive Assessment will be recruited for participation to exclude dementia.
Who cannot join
- Individuals with neurological conditions other than PD such as epilepsy, multiple sclerosis, brain tumors, etc. will be excluded to control for the effects these conditions have on the brain and behavior.
Trial locations and contacts
1 site in 1 country.
About this study
Learning deficits are frequent in individuals with Parkinson's Disease. Clear feedback is integral because through feedback individuals know whether they should stick with an action that they have been doing (if the feedback is positive), or change their course of action (if the feedback is negative). Learning though immediate feedback has been shown to be depended on the brain chemical dopamine that is disrupted in individuals with Parkinson's Disease. During learning, feedback can also be presented after a delay. The investigators propose that learning through delayed feedback will lead to greater learning in individuals with Parkinson's Disease, since learning through delayed feedback does not rely on dopamine. During the proposed paradigm, participants with Parkinson's Disease complete a multiple-choice test. After making their selection on the multiple-choice test, they either see feedback immediately or are given feedback 25 minute later after reviewing their selection on the multiple-choice test. The investigators hypothesize that participants will learn better when they are provided with delayed feedback.
- Conditions
- Parkinson Disease
- Being tested
- delayed feedback
- Keywords
- Parkinson Disease, learning, feedback
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed feedbackBehavioural
participants learn through either immediate or delayed feedback during a computer task
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease | Participants with Parkinson Disease; Single group. Receives: Behavioral: delayed feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent correct responses will be collected through the computer software
Response accuracy per trial
Measured: testing lasts 60 minutes and completed in 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Sep 2023
- Primary completion1 Apr 2025
- Study completion31 May 2025
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.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Dobryakova, Kessler Foundation
- Investigators
- Ekaterina Dobryakova, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217484
- Sponsor's protocol ID
- E-1228-23
- Status last verified
- Aug 2025
- First submitted
- 28 Dec 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effects of Delayed Feedback on Non-motor Symptoms in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06217484
- Acronym / sponsor ID
- E-1228-23
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, learning, feedback
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 22 Jan 2024 (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.
Learning deficits are frequent in individuals with Parkinson's Disease. Clear feedback is integral because through feedback individuals know whether they should stick with an action that they have been doing (if the feedback is positive), or change their course of action (if the feedback is negative). Learning though immediate feedback has been shown to be depended on the brain chemical dopamine that is disrupted in individuals with Parkinson's Disease. During learning, feedback can also be presented after a delay. The investigators propose that learning through delayed feedback will lead to greater learning in individuals with Parkinson's Disease, since learning through delayed feedback does not rely on dopamine. During the proposed paradigm, participants with Parkinson's Disease complete a multiple-choice test. After making their selection on the multiple-choice test, they either see feedback immediately or are given feedback 25 minute later after reviewing their selection on the multiple-choice test. The investigators hypothesize that participants will learn better when they are provided with delayed feedback.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease | – | Behavioral: delayed feedbackParticipants with Parkinson Disease; Single group. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Parkinson Disease
Key inclusion criteria (1 listed)
- Only participants with scores above 24/30 on the Montreal Cognitive Assessment will be recruited for participation to exclude dementia.
Key exclusion criteria (1 listed)
- Individuals with neurological conditions other than PD such as epilepsy, multiple sclerosis, brain tumors, etc. will be excluded to control for the effects these conditions have on the brain and behavior.
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 |
|---|---|---|
| delayed feedbackparticipants learn through either immediate or delayed feedback during a computer task | Behavioural | Parkinson Disease |
Primary outcome
Percent correct responses will be collected through the computer software
Time frame: testing lasts 60 minutes and completed in 1 day
Response accuracy per trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ekaterina Dobryakova, PhD principal investigator
Kessler Foundation
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 Kessler Foundation at 1 site in United States.
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: finished, as of the sponsor's last update on 5 Sep 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent correct responses will be collected through the computer software (time frame: testing lasts 60 minutes and completed in 1 day). 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 5 Sep 2025.