Cognitive Strategy Training for Parkinson's-Related Cognitive Impairment

(PMT2 Trial)

Recruiting at 2 trial locations

Overseen By Tasha Doty, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Levodopa/carbidopa

Must not be taking: Anticholinergics

Disqualifiers: Dementia, Stroke, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve memory in people with Parkinson's disease (PD). It involves two types of training: one focuses on practicing memory tasks, and the other, called Strategy Training (or Metacognitive Strategy Training), teaches specific strategies to enhance memory. The goal is to determine which method improves memory the most. Individuals with PD who have noticed memory problems and are currently taking certain medications might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance memory strategies for those with PD.

Will I have to stop taking my current medications?

You will not have to stop taking your current medications, but they should be stable for 4 weeks before starting the study and remain unchanged during the treatment period. Any changes after the treatment period will be tracked.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cognitive strategy training is safe for people with Parkinson's disease. One study found that participants completed the training without major issues, indicating it is well-tolerated. Research also found the training feasible, meaning people can do it without problems. This type of training is already used safely for brain injury and stroke recovery, suggesting its potential for Parkinson's. Overall, evidence suggests that the strategy training in this trial does not pose significant safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative techniques to improve cognitive function in people with Parkinson's disease, specifically targeting memory issues. Unlike standard treatments that often rely on medications to manage symptoms, this trial focuses on cognitive strategy training. It introduces specific strategies, like implementation intentions and strategic clock-checking, to help participants manage memory tasks more effectively. By integrating these strategies into real-life scenarios, the trial aims to empower participants to enhance their memory function independently, offering a potentially groundbreaking approach to cognitive rehabilitation for Parkinson’s-related cognitive impairment.

What evidence suggests that this trial's treatments could be effective for Parkinson's-related cognitive impairment?

Research has shown that strategy training, which participants in this trial may receive, could benefit people with Parkinson's Disease (PD) who experience difficulties with thinking and memory. Specifically, individuals who underwent this training had fewer daily life problems six months later compared to those who used other methods. This trial will compare strategy training with process training, which involves practicing tasks without specific strategy instruction. Strategy training teaches specific techniques to handle tasks more effectively, enhancing memory and planning skills. Although the effectiveness for PD is still under investigation, early results are promising and suggest it might help improve thinking skills. ^{1 2 3 4 6}

Who Is on the Research Team?

Erin Foster, PhD, OTD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion 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 am over 50 and diagnosed with typical Parkinson's disease.

Exclusion Criteria

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.

Contraindications or inability to participate in MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-6 months

Pre-training Assessment

Participants complete pre-training assessments and are randomized to treatment arms

1 week

1 visit (in-person)

Treatment

Participants undergo 8 training sessions over an 8-week period, focusing on process or strategy training

8 weeks

8 visits (in-person)

Post-training Assessment

Participants complete post-training assessments to evaluate immediate effects of the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for long-term effects of the intervention with assessments at 3, 6, and 12 months post-training

12 months

3 visits (web or mailed survey), 1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Strategy Training

Trial Overview 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.

How Is the Trial Designed?

Group I: Strategy Training Experimental Treatment 1 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 Training Active Control 1 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A pilot study involving 10 adults with stroke-related cognitive impairments showed that strategy training, when added to usual rehabilitation care, is feasible and well-accepted, with high participant retention and satisfaction rates.

Participants who received strategy training demonstrated significantly less disability at six months compared to those who received an attention control session, suggesting that this approach may effectively enhance recovery in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation. Skidmore, ER., Dawson, DR., Whyte, EM., et al.[2021]

Meta-cognitive strategy training, specifically the CO-OP method, was successfully implemented during inpatient rehabilitation for a patient with cognitive impairments after a right hemisphere stroke, showing its feasibility in a clinical setting.

The participant demonstrated significant improvements in rehabilitation engagement and functional independence, with notable increases in performance scores across various measures, suggesting potential benefits of this training approach for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. Skidmore, ER., Holm, MB., Whyte, EM., et al.[2021]

An adapted metacognitive strategy training protocol for 16 adults with mild to moderate aphasia was found to be feasible in an inpatient stroke rehabilitation setting, with therapists delivering the intervention effectively.

Participants showed significant improvement in disability, achieving a mean change of 21.8 on the Functional Independence Measure, comparable to results from previous trials involving individuals without aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive Strategy Training Is Feasible for People With Aphasia. Kersey, J., Evans, WS., Mullen, K., et al.[2022]

A novel client-centered cognitive strategy training intervention for people with Parkinson's disease (PD) was found to be feasible and well-accepted, with high participant satisfaction and engagement scores.

The intervention showed promising effects on self-identified cognitive problems, with significant improvements in functional ratings measured by the Canadian Occupational Performance Measure (COPM) after treatment sessions lasting an average of 9.2 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a cognitive strategy training intervention for people with Parkinson's disease. Foster, ER., Spence, D., Toglia, J.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11215553

Project Details - NIH RePORTER Strategy training is a practice standard for cognitive rehabilitation in brain injury and stroke, but its application in PD is novel. Moreover, the strategy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5568990/

Feasibility of a cognitive strategy training intervention for ... To investigate the feasibility of a novel client-centered cognitive strategy training intervention for people with Parkinson disease (PD).

3. withpower.com withpower.com/trial/phase-cognitive-dysfunction-9-2021-1690b

Cognitive Strategy Training for Parkinson's-Related ... Participants who received strategy training demonstrated significantly less disability at six months compared to those who received an attention control session ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07190404

Multicontext Approach for Cognitive Function in Parkinson ... Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI) ...

5. research.aota.org research.aota.org/ajot/article/79/5/7905205040/28426/A-Metacognitive-Strategy-Intervention-for-People

A Metacognitive Strategy Intervention for People With ... Metacognitive strategy interventions, such as the Multicontext (MC) Approach, may support daily function among people with PD (PwPD).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03836963

NCT03836963 | Cognitive Rehab for Parkinson's The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of ...