Cognitive Training in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495997
• Other study ID #: 2000033352
• Secondary ID: R56NS129540
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: Sule Tinaz, MD, PhD
• Phone: 203-737-6158
• Email: sule.tinaz[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Mental Imagery Training
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
• Psychoeducation
Participants will receive psychoeducation on cognition and brain health.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.