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Prospective Memory Training in Parkinson Disease

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ClinicalTrials.gov Identifier: NCT03582670
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Erin Foster, Washington University School of Medicine

Brief Summary:
The long term goal of this work is to reduce disability among people with Parkinson disease (PD) by enabling them to cope with cognitive decline so they can perform and participate in desired activities and roles. This project focuses on prospective memory, or the ability to remember to execute delayed intentions at the appropriate moment in the future. The current study tests the effects of two primary cognitive intervention approaches (process training & strategy training) on prospective memory performance in PD. The investigators will conduct a single-blind randomized controlled trial in which individuals with mild cognitive impairment in PD (PD-MCI; N = 90) will complete pre-training assessment, randomization to training group (control, process training, strategy training), four training sessions (process and strategy training groups), and post-training assessment.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Strategy Training Behavioral: Process Training Behavioral: Control Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Prospective Memory Training in Parkinson Disease
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Strategy Training Intervention
Study participants receive specific memory strategy training with training games, as well as feedback on accuracy and performance.
Behavioral: Strategy Training
Participants will attend four strategy training sessions total. In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the trainer teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based). In sessions 3 and 4, the trainer 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. At the end of each session after completing the training games, the trainer and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the trainer helps the participant develop written action plans to do so. Plans are reviewed (and modified if necessary) at each session.

Active Comparator: Process Training
Study participants attend training sessions and complete training games, but receive no specific strategy training
Behavioral: Process Training
Participants will attend four process training sessions in this group. In sessions 1 and 2, the trainer teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3 and 4, the trainer simply 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 trainer. Feedback on accuracy is provided after each training game. At the end of each session after completing both training games, the trainer 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. Of note, even this minimal level of discussion of real-life cognitive tasks is not typical of process training interventions, but we include it to control for that which is occurring in the strategy training group.

Control Group
Study participants do not attend any strategy training sessions.
Behavioral: Control Group
Participants in this group do not attend any sessions during the time the other groups are participating in the Strategy or Process Training




Primary Outcome Measures :
  1. Virtual Week [ Time Frame: 4 to 6 weeks ]
    A computerized board game that simulates daily life and real-world prospective memory challenges. Each circuit represents one day in which the participant completes time-appropriate activities and makes choices about them (i.e. the ongoing activity). Each day has 8 prospective memory tasks (4 event based, 4 time based). Participants complete a practice day and then three test days, with equivalent versions counterbalanced across Pre and Post testing. The main outcome variable is the proportion of correct prospective memory responses for each task type (12 event based, 12 time based). Change of performance on the Virtual Week from the Pre- and Post-session will be measured.

  2. Prospective and Retrospective Memory Questionnaire [ Time Frame: Through completion of the study, up to 16 weeks. ]
    Used to rate the participant's everyday retrospective and prospective memory. Change in scores on this questionnaire will be measured.



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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:

  • Males and females over age 50
  • Meet criteria for typical idiopathic PD
  • Hoehn & Yahr stage I-III
  • Treated with levodopa/carbidopa
  • Have PD with Mild Cognitive Impairment (PD-MCI) according to Movement Disorders Society (MDS) Level II diagnostic criteria.
  • Medications should be stable for 4 weeks prior with no changes planned during the study (we will document any unplanned changes).

Exclusion Criteria:

  • Dementia according to MDS criteria or MoCA score <21
  • Other neurological disorders,
  • Brain surgery
  • History of psychotic disorder
  • Change in medication during the study
  • Treatment with medications that interfere with cognition (e.g. anticholinergics)
  • Any condition that would interfere with participation (e.g., non-English speaking, significant current depression).

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): NCT03582670


Contacts
Contact: Erin Foster, PhD, OTD 3142861638 erfoster@wustl.edu
Contact: Tasha Doty, MA 3143627160 tdoty@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Erin Foster    314-286-1638    erfoster@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine

Responsible Party: Erin Foster, Assistant Professor of Occupational Therapy, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03582670     History of Changes
Other Study ID Numbers: 201709182
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erin Foster, Washington University School of Medicine:
Prospective Memory
Occupational Therapy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases