Cognitive Training in Parkinson's Disease

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Cognitive Training on Everyday Cognitive and Brain Function in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Mental Imagery Training
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic PD Age ≥ 40 years Expected to be on a stable dopaminergic medication regimen throughout the study period Exclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mental Imagery<br> | Behavioral: Mental Imagery Training<br>* Participants will practice mental imagery of everyday tasks daily for 6 weeks.<br>|
| Active Comparator: Psychoeducation<br> | Behavioral: Psychoeducation<br>* Participants will receive psychoeducation on cognition and brain health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life in Neurological Disorders (Neuro-QoL) Version 2 Cognitive Function scores | Neuro-QoL Version 2 Cognitive Function 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. | At baseline, 6 weeks, and 12 weeks. | 
| Change in task-specific whole-brain functional connectivity | Whole-brain functional connectivity during goal-directed tasks performed in the MRI scanner will be calculated for each subject. This measure will show the changes in the overall functional connectivity of the brain networks. Increase in task-specific whole-brain functional connectivity from baseline indicates improvement in task-specific whole-brain functional organization. | At baseline, 6 weeks, and 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in composite executive function test scores | Composite z-scores of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making A-B tests) will be calculated for each subject. Increase in these scores from baseline indicates improvement in executive function. | At baseline, 6 weeks, and 12 weeks. | 
| Change in local and global functional connectivity-based graph measures | Local and global network graph measures during tasks performed in the MRI scanner will be calculated for each subject. These measures will provide information about the changes in the local and global functional organization of the brain networks. Increase in these graph measures from baseline indicates improvement in the local and global functional organization of brain networks. | At baseline, 6 weeks, and 12 weeks. |