Prospective Memory Training in Parkinson Disease

NCT03582670 | Completed

• 1 other identifier: 201709182
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Prospective Memory; Occupational Therapy

Outcome Measures

Primary Outcomes (2)

• Virtual Week

  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.

  4 to 6 weeks

• Prospective and Retrospective Memory Questionnaire

  Used to rate the participant's everyday retrospective and prospective memory. Change in scores on this questionnaire will be measured.

  Through completion of the study, up to 16 weeks.

Study Arms (3)

Strategy Training Intervention

EXPERIMENTAL

Study participants receive specific memory strategy training with training games, as well as feedback on accuracy and performance.

Behavioral: Strategy Training

Process Training

ACTIVE COMPARATOR

Study participants attend training sessions and complete training games, but receive no specific strategy training

Behavioral: Process Training

Control Group

OTHER

Study participants do not attend any strategy training sessions.

Behavioral: Control Group

Interventions

Strategy Training BEHAVIORAL

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.

Strategy Training Intervention

Process Training BEHAVIORAL

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.

Process Training

Control Group BEHAVIORAL

Participants in this group do not attend any sessions during the time the other groups are participating in the Strategy or Process Training

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 11, 2018
• Study Start: October 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)