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Clinical Trials/NCT05495997
NCT05495997
Completed
N/A

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

Yale University1 site in 1 country30 target enrollmentJanuary 13, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Yale University
Enrollment
30
Locations
1
Primary Endpoint
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks
Status
Completed
Last Updated
8 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 13, 2023
End Date
September 18, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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

  • Change in Composite Executive Function T-scores at 6 Weeks(6 weeks)
  • Change in Composite Executive Function T-scores at 18 Weeks(18 weeks)

Study Sites (1)

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