Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-01-13
2024-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mental Imagery
Mental Imagery Training
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
Psychoeducation
Participants will receive psychoeducation on cognition and brain health.
Interventions
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Mental Imagery Training
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Psychoeducation
Participants will receive psychoeducation on cognition and brain health.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 40 years
* Expected to be on a stable dopaminergic medication regimen throughout the study period
Exclusion Criteria
* 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
* 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)
40 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Sule Tinaz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2000033352
Identifier Type: -
Identifier Source: org_study_id
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