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| ID | Type | Description | Link |
|---|---|---|---|
| R56NS129540 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mental Imagery | Experimental |
| |
| Psychoeducation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mental Imagery Training | Behavioral | Participants will practice mental imagery of everyday tasks daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sule Tinaz, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41482867 | Derived | 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 Jan 3:1-28. doi: 10.1080/09602011.2025.2608220. Online ahead of print. | |
| 40162247 | Derived | Cherry 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. |
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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.
Beginning 9 months and ending 36 months following article publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mental Imagery | Participants will practice mental imagery of everyday tasks daily for 6 weeks. |
| FG001 | Psychoeducation | Participants will receive psychoeducation on cognition and brain health. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mental Imagery | Participants will practice mental imagery of everyday tasks daily for 6 weeks. |
| BG001 | Psychoeducation | Participants will receive psychoeducation on cognition and brain health. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | T-score | Baseline and 6 weeks |
|
18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mental Imagery | Participants will practice mental imagery of everyday tasks daily for 6 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sule Tinaz | Yale School of Medicine | 203-737-6158 | sule.tinaz@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2023 | Jun 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 23, 2022 | Jun 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Psychoeducation | Behavioral | Participants will receive psychoeducation on cognition and brain health. |
|
| 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. |
| 18 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
|
|
|
| Primary | 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. | 15 in the Mental Imagery and 13 in the Psychoeducation group completed 18-week assessments. | Posted | Mean | Standard Deviation | T-score | 18 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T-score | 6 weeks |
|
|
|
|
| Secondary | 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. | 15 in the Mental Imagery group and 13 in the Psychoeducation group completed 18-week assessments | Posted | Mean | Standard Deviation | T-score | 18 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Psychoeducation | Participants will receive psychoeducation on cognition and brain health. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |