Cognitive Training in Parkinson's Disease

NCT ID: NCT05495997

Last Updated: 2025-08-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2024-09-18

Brief Summary

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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).

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mental Imagery

Group Type EXPERIMENTAL

Mental Imagery Training

Intervention Type BEHAVIORAL

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

Psychoeducation

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

Participants will receive psychoeducation on cognition and brain health.

Interventions

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Mental Imagery Training

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

Intervention Type BEHAVIORAL

Psychoeducation

Participants will receive psychoeducation on cognition and brain health.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sule Tinaz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40162247 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R56NS129540

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000033352

Identifier Type: -

Identifier Source: org_study_id

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