Prospective Memory Training in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Virtual Week
研究概览
简要总结
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.
详细描述
RANDOMIZATION
Once a participant is enrolled in the study and completes the Pre-testing session (described in detail below), they will be randomized into one of the following study groups:
- Process Training Group - the trainer teaches the participant about event- and time-based prospective memory tasks, respectively. The trainer simply tells the participant that s/he will be practicing both types of tasks in training games.
- Strategy Training Group - In training 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; and instructs in their use before and during the training games.
- Contro1 Group - Receives no training sessions. Only Completes the PRE, POST and 1-month & 3-month Follow Up portions of the study.
STUDY VISITS
- On the day of their testing appointment, participants will arrive at their designated location at the WUSM Movement Disorders Clinic for their testing session. All participants will provide written informed consent before their first testing session begins, and the examiner will answer any questions before beginning testing. Scheduled participants will be mailed or emailed (depending on their preference) study information and a copy of the consent form. Participants will receive reminder calls 1-2 days before their appointments.
- Demographics will be collected on all participants. This includes age, gender, years of education, living status, race, and ethnicity after consent is obtained. This can be completed online via Redcap or on paper at the testing session.
- Investigators will collect PD clinical characteristics from the Movement Disorders Clinical Record. Clinical Characteristics includes: Hoehhn & Yahr Stage, year of first PD symptoms, year of initial PD diagnosis, MoCA score at most recent clinic visit, Side of symptom onset, type of symptom onset (tremor vs. bradykinesia), PD medications, and most recent Unified Parkinson Disease Rating Scale Motor Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
结局指标
主要结局
Virtual Week
时间窗: 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.
Prospective and Retrospective Memory Questionnaire
时间窗: 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.
次要结局
未报告次要终点