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Behavioral Intervention
Cognitive Strategy Training for Parkinson's-Related Cognitive Impairment (PMT2 Trial)
N/A
Waitlist Available
Led By Erin Foster, PhD, OTD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hoehn & Yahr stage I-III
Treated with levodopa/carbidopa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at baseline, pre-treatment session; one week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.
Awards & highlights
PMT2 Trial Summary
This trial will study whether process or strategy training can help improve cognitive skills in people with Parkinson's disease.
Who is the study for?
This trial is for people over 50 with typical idiopathic Parkinson's Disease (stages I-III), taking levodopa/carbidopa, and who have memory complaints but not dementia. Participants need an informant for ratings, stable medication use, and must be able to undergo MRI scans without issues.Check my eligibility
What is being tested?
The study tests two types of memory training in a single-blind randomized controlled trial: process training versus strategy training. Participants will undergo pre-training assessments, complete eight sessions over four weeks, post-training assessments within a week after finishing the sessions, and follow-ups at 3 months, 6 months, and one year.See study design
What are the potential side effects?
Since this trial involves cognitive strategy trainings rather than medications or invasive procedures, there are no direct physical side effects expected from the interventions being studied.
PMT2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Parkinson's disease is in the early to mid stages.
Select...
I am currently taking levodopa/carbidopa.
PMT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at baseline, pre-treatment session; one week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at baseline, pre-treatment session; one week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Bangor Goal Setting Interview goal attainment after 5-weeks and 12-month post-intervention.
Change in The Prospective and Retrospective Memory Questionnaire scores after 5-weeks, 3-months, 6-months, and 12-month post-intervention.
Change in Virtual Week Computer-based Memory Test performance after 5-weeks and 12-month post-intervention.
PMT2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Strategy TrainingExperimental Treatment1 Intervention
Consists of 8-90 minute sessions over 8 weeks. In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the therapist teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based) and instructs in their use before and during the training games. In sessions 3-8, the tester tells the participant s/he will be practicing both types of tasks in the training games and can support the participant's strategy use if needed. Feedback on accuracy and strategy use are provided after each training game. After completing the training games, the therapist and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the therapist helps the participant develop written action plans to do so. Plans and goals are reviewed and modified, if necessary, at each session.
Group II: Process TrainingActive Control1 Intervention
Consists of 8, 90 minute sessions over 8 weeks. In sessions 1 and 2, the therapist teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3-8, the tester tells the participant that s/he will be practicing both types of tasks in the training games. In all sessions, the participant completes the training games with no strategy instruction from the therapist. Feedback on accuracy is provided after each training game. This is typical of a process training approach and expects that practice of the training tasks will improve prospective memory ability per se or that participants will develop effective strategies for completing prospective memory tasks on their own. At the end of each session, the therapist reminds the participant of his/her real-life prospective memory goals, provides a handout that lists the goals, and instructs the participant to try to complete them as intended. Goals are reviewed and modified if necessary.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,509 Total Patients Enrolled
Erin Foster, PhD, OTDPrincipal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My Parkinson's disease is in the early to mid stages.My medications have been the same for the last 4 weeks and won't change during the study.I do not have severe neurological disorders, major psychiatric conditions, or a history of drug abuse.I have mental health symptoms like anxiety or depression, but they don't stop me from participating.I am over 50 and diagnosed with typical Parkinson's disease.You have functional MRI data that can be used for the study.I am not taking any medications that affect my thinking.You have reported issues with your memory during a phone screening.I am currently taking levodopa/carbidopa.You have been diagnosed with significant memory loss or have a low score on a memory test.You have any other condition that would make it difficult for you to take part in the study, such as not being able to speak English or having significant depression.
Research Study Groups:
This trial has the following groups:- Group 1: Process Training
- Group 2: Strategy Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research project still underway?
"As indicated on clinicaltrials.gov, the recruitment period for this study has ended and it is not currently seeking applicants. The trial was first uploaded to the database in November 2021 and last modified in January 2022; however, there are an abundance of other trials that are inviting patients at present."
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