Cognitive Rehab for Parkinson's
Cognitive Rehabilitation for Veterans With Parkinson's Disease
2 other identifiers
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedResults Posted
Study results publicly available
July 22, 2024
CompletedJuly 22, 2024
March 1, 2024
2.7 years
January 28, 2019
March 21, 2024
March 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (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 is used to compute the composite score. -3 and +3 are the minimum and maximum values. Higher scores indicated better performance.
week 0 (before intervention begins), 8 weeks
Study Arms (3)
cognitive and memory strategy training
EXPERIMENTALThe 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.
cognitive and memory strategy control training
ACTIVE COMPARATORThe 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.
active control for cognitive and memory strategy training
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- years or older
- Speak and read English
You may not qualify if:
- Dementia
- Failure to demonstrate decision making capacity
- Cholinesterase inhibitor medication
- History of deep brain stimulation surgery
- Severe depression
- Severe anxiety
- Severe apathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sandra Kletzel
- Organization
- Edward Hines Jr. VA Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra L. Kletzel, PhD BA
Edward Hines Jr. VA Hospital, Hines, IL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2019
First Posted
February 11, 2019
Study Start
January 27, 2020
Primary Completion
October 1, 2022
Study Completion
December 30, 2022
Last Updated
July 22, 2024
Results First Posted
July 22, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- 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.
- Access Criteria
- These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.
Raw and/or normalized data will be made available in the form of Excel files.