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Completed

NCT Number: NCT05495997

Cognitive Training in Parkinson's Disease

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mental Imagery Training

Behavioral

Participants will practice mental imagery of everyday tasks daily for 6 weeks.

Psychoeducation

Behavioral

Participants will receive psychoeducation on cognition and brain health.

Primary outcomes

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

    Time frame: Baseline and 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.

  2. Change in Neuro-QoL CF v2 T-scores at 18 Weeks

    Time frame: 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 outcomes

  1. Change in Composite Executive Function T-scores at 6 Weeks

    Time frame: 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.

  2. Change in Composite Executive Function T-scores at 18 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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