search
Back to results

Cognitive Training in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mental Imagery Training
Psychoeducation
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Yale School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mental Imagery

Psychoeducation

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 8, 2022
Last Updated
August 9, 2023
Sponsor
Yale University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT05495997
Brief Title
Cognitive Training in Parkinson's Disease
Official Title
Effects of Cognitive Training on Everyday Cognitive and Brain Function in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mental Imagery
Arm Type
Experimental
Arm Title
Psychoeducation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mental Imagery Training
Intervention Description
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Participants will receive psychoeducation on cognition and brain health.
Primary Outcome Measure Information:
Title
Change in Quality of life in Neurological Disorders (Neuro-QoL) Version 2 Cognitive Function scores
Description
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.
Time Frame
At baseline, 6 weeks, and 12 weeks.
Title
Change in task-specific whole-brain functional connectivity
Description
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.
Time Frame
At baseline, 6 weeks, and 12 weeks.
Secondary Outcome Measure Information:
Title
Change in composite executive function test scores
Description
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.
Time Frame
At baseline, 6 weeks, and 12 weeks.
Title
Change in local and global functional connectivity-based graph measures
Description
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.
Time Frame
At baseline, 6 weeks, and 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sule Tinaz, MD, PhD
Phone
203-737-6158
Email
sule.tinaz@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sule Tinaz, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sule Tinaz, MD, PhD
Phone
203-737-6158
Email
sule.tinaz@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This study will produce unique clinical, cognitive, behavioral, and imaging datasets obtained from subjects with mild-to-moderate Parkinson's disease at baseline and at two time points - immediate and delayed - post-intervention. These datasets will be made available for research purposes to qualified individuals within the scientific community. We will plan on sharing these datasets on a free web-based platform such as the Neuroimaging Data Repository of the Neuroimaging Tools & Resources Collaboratory (NITRC) (www.nitrc.org). First, these datasets will be de-identified using the anonymization toolkit of the Repository to exclude any personal health information or personally identifying information. The release of the data will be blocked using the "quarantine" function in the toolkit until the completion of the anonymization process. Each dataset will be stored with a unique code.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.

Learn more about this trial

Cognitive Training in Parkinson's Disease

We'll reach out to this number within 24 hrs