Parkinson DiseaseNCT05495997
Cognitive Training in Parkinson's Disease
A study testing Mental Imagery Training and Psychoeducation in people with Parkinson Disease, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether cognitive training will improve cognitive and brain functions in people with Parkinson's Disease (PD) during activities of daily living using cognitive evaluations and magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mental Imagery Training and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 18 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD
- Age ≥ 40 years
- Expected to be on a stable dopaminergic medication regimen throughout the study period
Who cannot join
- Non-English speaking
- Pregnancy
- Breastfeeding
- Excessive alcohol consumption (> 7 drinks per week for women, > 14 drinks per week for men) or illicit substance use
- History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures
- History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive-compulsive disorder
Show all 16Show fewer
- History of head injury with loss of consciousness longer than a few minutes
- Metallic surgical implants or traumatically implanted metallic foreign bodies
- Inability to lie flat for about an hour in the MRI scanner
- Discomfort being in small, enclosed spaces
- Dementia at screening (Montreal Cognitive Assessment score < 21/30)
- Cognitive problems in activities of daily living suggestive of more than mild cognitive impairment (PD Cognitive Functional Rating Scale > 4)
- Mild cognitive impairment according to the Movement Disorders Society (MDS) Level II comprehensive assessment criteria (> 1.5 standard deviations below the norm in two tests in a single cognitive domain or in one test in two separate cognitive domains, with the exception that the executive domain scores can be up to 2 standard deviations below the norm)
- Hoehn \& Yahr stage > 3 (i.e., able to stand and walk, but not fully independent)
- Focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism
- Motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., MDS-Unified PD Rating Scale resting tremor score > 2 in limbs, head/chin tremor, or more than mild dyskinesia by history or exam)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Effects of Cognitive Training on Everyday Cognitive and Brain Function in Parkinson's Disease
The purpose of this research study is to determine whether cognitive training will improve cognitive and brain functions in people with Parkinson's Disease (PD) during activities of daily living using cognitive evaluations and magnetic resonance imaging (MRI).
- Conditions
- Parkinson Disease
- Being tested
- Mental Imagery Training, Psychoeducation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Imagery TrainingBehavioural
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
PsychoeducationBehavioural
Participants will receive psychoeducation on cognition and brain health.
| Study group | Role | What they receive |
|---|---|---|
| Mental Imagery | Experimental | Not described Receives: Behavioral: Mental Imagery Training |
| Psychoeducation | Active comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
Measured: Baseline and 6 weeks
Change in Neuro-QoL CF v2 T-scores at 18 Weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
Measured: 18 weeks
Secondary outcomes (2)
Change in Composite Executive Function T-scores at 6 Weeks
T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function.
Measured: 6 weeks
Change in Composite Executive Function T-scores at 18 Weeks
T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start13 Jan 2023
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Sule Tinaz, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495997
- Sponsor's protocol ID
- 2000033352
- Other IDs
- R56NS129540
- Status last verified
- Jul 2025
- First submitted
- 8 Aug 2022
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will produce unique clinical, cognitive, behavioral, and imaging datasets obtained from subjects with mild-to-moderate Parkinson's disease at baseline and at two time points - immediate and delayed - post-intervention. The de-identified datasets will be made available for research purposes to qualified individuals within the scientific community upon request.
Publications
Cherry J, Nelson AM, Robinson LA, Goldstein J, Vives-Rodriguez A, Sharp E, Tinaz S. Feasibility and potential effects of mental imagery training on subjective cognitive function and brain connectivity in people with Parkinson's disease: A randomized pilot trial. Neuropsychol Rehabil. 2026 Sep;36(8):1588-1615. doi: 10.1080/09602011.2025.2608220. Epub 2026 Jan 3.
PubMed 41482867Cherry J, Nelson AM, Robinson LA, Goldstein J, Vives-Rodriguez A, Sharp E, Tinaz S. Effects of mental imagery training on cognitive function and brain connectivity in people with Parkinson's disease: A randomized pilot trial. medRxiv [Preprint]. 2025 Mar 15:2025.03.14.25324001. doi: 10.1101/2025.03.14.25324001.
PubMed 40162247
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Training on Everyday Cognitive and Brain Function in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05495997
- Acronym / sponsor ID
- 2000033352
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine whether cognitive training will improve cognitive and brain functions in people with Parkinson's Disease (PD) during activities of daily living using cognitive evaluations and magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Imagery | Experimental | Behavioral: Mental Imagery Training |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic PD
- Age ≥ 40 years
- Expected to be on a stable dopaminergic medication regimen throughout the study period
Key exclusion criteria (16 listed)
- Non-English speaking
- Pregnancy
- Breastfeeding
- Excessive alcohol consumption (> 7 drinks per week for women, > 14 drinks per week for men) or illicit substance use
- History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures
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 |
|---|---|---|
| Mental Imagery TrainingParticipants will practice mental imagery of everyday tasks daily for 6 weeks. | Behavioural | Mental Imagery |
| PsychoeducationParticipants will receive psychoeducation on cognition and brain health. | Behavioural | Psychoeducation |
Primary outcome
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks
Time frame: Baseline and 6 weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
Change in Neuro-QoL CF v2 T-scores at 18 Weeks
Time frame: 18 weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
2 secondary outcomes
Change in Composite Executive Function T-scores at 6 Weeks
Time frame: 6 weeks
Change in Composite Executive Function T-scores at 18 Weeks
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41482867Cherry J, Nelson AM, Robinson LA, Goldstein J, Vives-Rodriguez A, Sharp E, Tinaz S. Feasibility and potential effects of mental imagery training on subjective cognitive function and brain connectivity in people with Parkinson's disease: A randomized pilot trial. Neuropsychol Rehabil. 2026 Sep;36(8):1588-1615. doi: 10.1080/09602011.2025.2608220. Epub 2026 Jan 3.
- Derived from this study: PubMed 40162247Cherry J, Nelson AM, Robinson LA, Goldstein J, Vives-Rodriguez A, Sharp E, Tinaz S. Effects of mental imagery training on cognitive function and brain connectivity in people with Parkinson's disease: A randomized pilot trial. medRxiv [Preprint]. 2025 Mar 15:2025.03.14.25324001. doi: 10.1101/2025.03.14.25324001.
- Individual participant dataSharing planned: Yes. This study will produce unique clinical, cognitive, behavioral, and imaging datasets obtained from subjects with mild-to-moderate Parkinson's disease at baseline and at two time points - immediate and delayed - post-intervention. The de-identified datasets will be made available for research purposes to qualified individuals within the scientific community upon request.
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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.
Sule Tinaz, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Imagery Training and Psychoeducation in people with Parkinson Disease, run by Yale University 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 3 inclusion and 16 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 11 Aug 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?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495997, which also lists 2 linked publications.
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 11 Aug 2025.