Prospective Memory Impairment in Parkinson Disease-related Cognitive Decline: Intervention and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Bangor Goal Setting Interview goal attainment after 5-weeks and 12-month post-intervention.
研究概览
简要总结
The investigators will aim enroll participants into our study within 3-6 months after their parent study visit so the investigators can utilize some key data points (e.g. PD-MCI diagnosis, rs-fcMRI data) from that study. PD participants will participate in a single-blind RCT with two treatment arms: process training and strategy training (Fig 4). They will complete pre-training assessment (Pre), be randomized to treatment arm (1:1 ratio stratified by sex), and then complete 8 training sessions over an 8-week period. They will return within 1 week for post-training assessment (Post) and then will complete Follow-up (FU) assessments via web or mailed survey 3 and 6 months after training ends. They will complete a 12mo FU assessment in person in conjunction with their annual parent study visit. HC participants will complete prospective memory assessment at one time point coinciding with (or within 3-6 months of) their parent study visit to determine whether any relationships observed between rs-fcMRI data and prospective memory are specific to PD.
详细描述
Parkinson disease (PD) causes cognitive deficits that can impair instrumental activities of daily living function and quality of life (QOL) even in the absence of dementia. Currently, there are no treatments to address this pressing burden and, even worse, some medical treatments for PD can exacerbate cognitive deficits. For these reasons, behavioral interventions that attenuate the negative functional consequences of cognitive decline in PD and thus potentially delay the onset of dementia are in high demand. An intervention that enables people with PD to remember to perform necessary and meaningful daily activities could improve or maintain their independence, disease self-management, participation in society, and reduce caregiver burden. The primary goal of this study is to determine the efficacy of such an intervention. Importantly, in doing so, the investigators will directly address a critical point of contention in cognitive intervention research: Which approach (process or strategy training) is the best option for producing functionally-relevant benefits for people with PD? Additionally, the study team will investigate behavioral and neurobiological correlates of prospective memory in PD, including individual characteristics that may predict treatment response. This work will lead to a targeted and tailored biobehavioral intervention that optimizes function, promotes QOL, and improves the long-term management of a common chronic neurological condition. It will move the field of rehabilitation forward by providing valuable theoretical and practical information related to the type of cognitive intervention approach that is most appropriate for people with PD. This then will stimulate and justify the channeling of future research efforts and funding toward further development, testing, dissemination, and implementation of said approach.
Primary Outcomes:
Aim 1. Laboratory prospective memory performance - The Virtual Week test will be administered to PD participants at Pre and Post to assess near transfer of training objectively (primary endpoint). It will also be administered to PD participants at 12mo FU to explore long term training effects (secondary endpoint) and to HC participants at Pre to investigate neural mechanisms of prospective memory performance (Aim 3). It is 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. Embedded in each day are 8 prospective memory tasks (4 event, 4 time). Participants complete a practice day and then 4 test days; equivalent versions are counterbalanced across testing sessions. The main outcome variable is prospective memory accuracy, defined as the proportion of correct prospective memory responses (32 total: 16 event, 16 time). To further explore the effects of time-based training, the investigators will record strategic clock-checking behavior by requiring participants to click a button to reveal the virtual time of day.
Aim 2. Reported everyday prospective memory: (2a) General everyday prospective memory function - The Prospective and Retrospective Memory Questionnaire (PRMQ)will be administered via web-based or mailed survey to PD participants and informants at Pre, Post and 3mo FU to assess far transfer of training (primary endpoint), to PD participants and informants at 6mo and 12mo FU to explore long term training effects (secondary endpoint), and to HC participants at Pre to determine neural mechanisms of everyday prospective memory (Aim 3). The PRMQ is the most widely used questionnaire for everyday prospective memory. Participants rate the frequency of 8 everyday prospective memory failures (1=Never, 5=Very Often), item scores are summed, and higher scores indicate worse everyday prospective memory. The PRMQ includes environment- and self-cued subscales (4 items each) that parallel the event- and time-based task distinction, respectively. (2b) Personalized real-life prospective memory tasks - The Bangor Goal-Setting Interview (BGSI)offers a standardized means of eliciting individual goals and rating goal attainment over time and has been successfully used in cognitive rehabilitation RCTs with older adults, including those with mild to moderate dementia. During the first two training sessions, after an explanation of the prospective memory task types (session 1: event, session 2: time), participants will complete the BGSI with the trainer to identify and set goals for 3-6 real-life prospective memory tasks they anticipate having to complete over the training period. They and their informants will rate their Pre and Post attainment of these goals on a 10-point scale (1=never remember to do; 10=always remember to do). Goal attainment ratings are averaged to yield mean attainment scores.
Additional measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and outcomes assessor will be blind to which cognitive training a participant will be randomized.
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 who meet criteria for typical idiopathic PD
- •Hoehn & Yahr stage I-III,
- •Treated with levodopa/carbidopa
- •Have subjective memory complaints (as identified in phone screen),
- •Have an informant to complete relevant ratings,
- •Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); changes over the follow-up period will be tracked and accounted for as appropriate.
排除标准
- •Dementia according to MDS criteria or MoCA score <
- •Other neurological disorders (e.g. stroke, seizures), brain surgery, severe systemic diseases, major psychiatric disorder or history of psychotic symptoms (e.g. schizophrenia, bipolar disorder, delusions, hallucinations), or drug abuse.
- •Treatment with medications that interfere with cognition (e.g. anticholinergics).
- •Any other condition that would interfere with participation (e.g., non-English speaking, significant current depression).
- •Psychiatric conditions/ symptoms that are common in PD (e.g. anxiety, depression) are allowed if they are deemed insufficient to interfere with participation.
研究组 & 干预措施
Strategy Training
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.
干预措施: Strategy Training (Time- and Event- Based) (Behavioral)
Process Training
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.
结局指标
主要结局
Change in Bangor Goal Setting Interview goal attainment after 5-weeks and 12-month post-intervention.
时间窗: Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.
A standardized measure that elicits individual goals and rating goal attainment over time
Change in Virtual Week Computer-based Memory Test performance after 5-weeks and 12-month post-intervention.
时间窗: Administered at baseline, pre-treatment session; One week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.
A computer-based prospective memory test that simulates a real day where a person has to remember to do tasks.
Change in The Prospective and Retrospective Memory Questionnaire scores after 5-weeks, 3-months, 6-months, and 12-month post-intervention.
时间窗: 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.
Participant-reported everyday prospective memory
次要结局
未报告次要终点
研究者
Erin Foster
Assistant Professor
Washington University School of Medicine