Cognitive Training in Parkinson's Disease

Not Applicable

Completed

Conditions: Parkinson Disease

Registration Number: NCT05495997

Lead Sponsor: Yale University

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Composite Executive Function T-scores at 6 Weeks	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.
Change in Composite Executive Function T-scores at 18 Weeks	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.