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Cognitive Rehab for Parkinson's

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ClinicalTrials.gov Identifier: NCT03836963
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Mild Cognitive Impairment Behavioral: cognitive training Behavioral: active control cognitive training Behavioral: memory strategy training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control trial. three arms to the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation for Veterans With Parkinson's Disease
Estimated Study Start Date : September 16, 2019
Estimated Primary Completion Date : August 9, 2021
Estimated Study Completion Date : August 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cognitive and memory strategy training
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.
Behavioral: cognitive training
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.

Behavioral: memory strategy training
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.

Active Comparator: cognitive and memory strategy control training
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.
Behavioral: cognitive training
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.

Behavioral: memory strategy training
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.

Active Comparator: active control for cognitive and memory strategy training
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.
Behavioral: active control cognitive training
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.

Behavioral: memory strategy training
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 Measures :
  1. change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score [ Time Frame: week 0 (before intervention begins), 8 weeks, 12 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836963


Contacts
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Contact: Sandra L Kletzel, PhD BA (708) 202-5735 Sandra.Kletzel@va.gov
Contact: Theresa L Pape, DrPH MA BS (708) 202-8387 ext 24953 theresa.pape@va.gov

Locations
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United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL Not yet recruiting
Hines, Illinois, United States, 60141-5000
Contact: William Wolf, PhD    708-202-8387    William.Wolf@va.gov   
Contact: Susan Andrese, MHA    (708) 202-8387 ext 27447    Susan.Andrese@va.gov   
Principal Investigator: Sandra L. Kletzel, PhD BA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sandra L. Kletzel, PhD BA Edward Hines Jr. VA Hospital, Hines, IL

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03836963     History of Changes
Other Study ID Numbers: N3015-P
RX003015 ( Other Grant/Funding Number: Department of Veterans Affairs )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw and/or normalized data will be made available in the form of Excel files.
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.

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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

Keywords provided by VA Office of Research and Development:
Parkinson's disease
cognition
cognitive training
prospective memory
executive function

Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders