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Cognitive Rehab for Parkinson's

Primary Purpose

Parkinson's Disease, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive training
active control cognitive training
memory strategy training
memory strategy training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, cognition, cognitive training, prospective memory, executive function

Eligibility Criteria

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

Inclusion Criteria:

  • Veterans who seek services at Hines VA Hospital
  • Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
  • Meet criteria for having mild cognitive impairment
  • Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT
  • 50 years or older
  • Speak and read English

Exclusion Criteria:

  • Dementia
  • Failure to demonstrate decision making capacity
  • Cholinesterase inhibitor medication
  • History of deep brain stimulation surgery
  • Severe depression
  • Severe anxiety
  • Severe apathy

Sites / Locations

  • Edward Hines Jr. VA Hospital, Hines, IL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

cognitive and memory strategy training

cognitive and memory strategy control training

active control for cognitive and memory strategy training

Arm Description

The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.

The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.

The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.

Outcomes

Primary Outcome Measures

change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score
The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score

Secondary Outcome Measures

Full Information

First Posted
January 28, 2019
Last Updated
February 24, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03836963
Brief Title
Cognitive Rehab for Parkinson's
Official Title
Cognitive Rehabilitation for Veterans With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine the feasibility of an at-home cognitive training program that incorporates both memory training and online computerized cognitive training (CCT) software. Data will also be collected to determine if this program improves thinking and memory as well as everyday function. The hypothesis is that memory and cognitive training combined , compared to memory training alone or will lead to greater improvements in cognitive performance and daily function.
Detailed Description
The objective of this study is to examine feasibility of an at-home cognitive rehabilitation program that incorporates both prospective implementation intentions strategies (PRIIS) and an existing web-based executive function (EF) computerized cognitive training (CCT) software for Veterans with Parkinson's disease (PD) and to collect pilot data to determine the impact of this program on cognition and everyday function. The central hypothesis is that CCT+PRIIS, compared to CCT alone and an active control group, will lead to greater improvements in cognitive performance and daily function. This innovative study uses a set of on-line training games that target aspects of EF susceptible in PD and trains the transfer of cognitive benefits to everyday function, using PRIIS, for Veterans with PD and mild cognitive impairment in executive function. Additionally, training is conducted at home allowing for convenience and flexibility for participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Mild Cognitive Impairment
Keywords
Parkinson's disease, cognition, cognitive training, prospective memory, executive function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial. three arms to the study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive and memory strategy training
Arm Type
Experimental
Arm Description
The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
Arm Title
cognitive and memory strategy control training
Arm Type
Active Comparator
Arm Description
The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
Arm Title
active control for cognitive and memory strategy training
Arm Type
Active Comparator
Arm Description
The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
Intervention Type
Behavioral
Intervention Name(s)
cognitive training
Intervention Description
Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
Intervention Type
Behavioral
Intervention Name(s)
active control cognitive training
Intervention Description
The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
Intervention Type
Behavioral
Intervention Name(s)
memory strategy training
Intervention Description
the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.
Intervention Type
Behavioral
Intervention Name(s)
memory strategy training
Intervention Description
the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.
Primary Outcome Measure Information:
Title
change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score
Description
The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score
Time Frame
week 0 (before intervention begins), 8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans who seek services at Hines VA Hospital Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria Meet criteria for having mild cognitive impairment Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT 50 years or older Speak and read English Exclusion Criteria: Dementia Failure to demonstrate decision making capacity Cholinesterase inhibitor medication History of deep brain stimulation surgery Severe depression Severe anxiety Severe apathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra L. Kletzel, PhD BA
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-3030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw and/or normalized data will be made available in the form of Excel files.
IPD Sharing Time Frame
Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available.
IPD Sharing Access Criteria
These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.

Learn more about this trial

Cognitive Rehab for Parkinson's

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