Cognitive Training in Parkinson's Disease

Yale University

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Psychoeducation; Behavioral: Mental Imagery Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05495997

R56NS129540 (U.S. NIH Grant/Contract)

2000033352

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Mental Imagery

Experimental group

Treatment:

Behavioral: Mental Imagery Training

Psychoeducation

Active Comparator group

Treatment:

Behavioral: Psychoeducation