Cognitive Training in Parkinson's Disease

NCT05495997 | Completed Results

• 2 other identifiers: 2000033352R56NS129540
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

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

  Baseline and 6 weeks

• Change in Neuro-QoL CF v2 T-scores at 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.

  18 weeks

Secondary Outcomes (2)

• 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 Arms (2)

Mental Imagery

EXPERIMENTAL

Behavioral: Mental Imagery Training

Psychoeducation

ACTIVE COMPARATOR

Behavioral: Psychoeducation

Interventions

Mental Imagery Training BEHAVIORAL

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

Mental Imagery

Psychoeducation BEHAVIORAL

Participants will receive psychoeducation on cognition and brain health.

Psychoeducation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD
• Age ≥ 40 years
• Expected to be on a stable dopaminergic medication regimen throughout the study period

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

• Cherry J, Nelson AM, Robinson LA, Goldstein J, Vives-Rodriguez A, Sharp E, Tinaz S. Feasibility and potential effects of mental imagery training on subjective cognitive function and brain connectivity in people with Parkinson's disease: A randomized pilot trial. Neuropsychol Rehabil. 2026 Jan 3:1-28. doi: 10.1080/09602011.2025.2608220. Online ahead of print.

  PMID: 41482867 DERIVED

• Cherry J, Nelson AM, Robinson LA, Goldstein J, Vives-Rodriguez A, Sharp E, Tinaz S. Effects of mental imagery training on cognitive function and brain connectivity in people with Parkinson's disease: A randomized pilot trial. medRxiv [Preprint]. 2025 Mar 15:2025.03.14.25324001. doi: 10.1101/2025.03.14.25324001.

  PMID: 40162247 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Sule Tinaz
• Organization: Yale School of Medicine

sule.tinaz@yale.edu

203-737-6158

Study Officials

• Sule Tinaz, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: January 13, 2023
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: August 11, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication.

Locations

US (1)