Multicontext Approach for Parkinson's Disease

(MC4PD R01 Trial)

Overseen By Tasha D Doty, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Dementia, Stroke, Seizures, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 17

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist people with early-stage Parkinson's disease experiencing worsening thinking or memory. The focus is on teaching strategies to manage everyday cognitive challenges, aiming to improve quality of life, unlike past methods that offered limited help. Participants will work with occupational therapists over several sessions to develop these strategies. It suits those with Parkinson's who feel their cognitive skills are declining and can identify daily cognitive challenges they want to tackle.

As an unphased trial, this study offers a unique opportunity to explore innovative strategies that could significantly enhance participants' daily living.

Will I have to stop taking my current medications?

You don't 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 sessions.

What prior data suggests that the Multicontext Approach is safe for people with Parkinson's Disease?

Research has shown that the Multicontext Approach is safe and well-tolerated for people with Parkinson's Disease. An initial study reported no negative side effects, and participants completed the treatment sessions successfully. The approach proves practical and acceptable for those who try it. This includes the version with extra booster sessions, which earlier trials also found to have no safety issues. Overall, the Multicontext Approach maintains a strong safety record in studies to date. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multicontext Approach for Parkinson's Disease because it takes a comprehensive method that goes beyond typical medication or physical therapy. Unlike standard treatments that mainly focus on managing symptoms, this approach addresses cognitive challenges by involving various contexts to improve everyday functioning. The MC + Booster variant even adds additional sessions to reinforce skills, which could lead to longer-lasting benefits. This innovative method aims to offer a more holistic way to enhance the quality of life for people with Parkinson's.

What evidence suggests that the Multicontext Approach is effective for cognitive decline in Parkinson's disease?

Studies have shown that the Multicontext Approach, a method to improve thinking skills, can help people with Parkinson's Disease (PD) who do not have dementia. This approach increases awareness of thinking and teaches strategies to manage daily tasks better. In this trial, researchers will divide participants into groups: one group will receive the Multicontext Approach, while another will undergo cognitive process training as a control. Some participants from the Multicontext Approach group will also receive extra follow-up sessions, which might lead to even greater benefits. Overall, the Multicontext Approach appears promising for enhancing daily function and quality of life in individuals with PD who face thinking challenges. ^{1 2 3 6 7}

Who Is on the Research Team?

Erin R Foster, PhD, OTDR/L

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with early Parkinson's Disease who experience mild cognitive decline. Participants will work with an occupational therapist and must be able to attend multiple treatment sessions and follow-up visits over a year.

Inclusion Criteria

I am over 50 and diagnosed with Parkinson's disease.

My Parkinson's disease is in the early to mid stages.

I feel my memory or thinking skills have worsened and face daily challenges because of it.

Exclusion Criteria

I have a neurological condition like stroke or seizures.

Dementia according to MDS criteria or MoCA score <21

Current or history of major psychiatric disorder or psychotic symptoms (e.g., schizophrenia, bipolar disorder, delusions, hallucinations), drug abuse. Psychiatric conditions/symptoms that are common in PD (e.g., anxiety, depression) are permitted if deemed insufficient to interfere with participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline cognitive testing session

1 week

1 visit (in-person)

Treatment

Participants receive 10 cognitive treatment sessions with a trained occupational therapist

10 weeks

10 visits (in-person, 1x/week)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (1-week, 3-months, 6-months, and 12-months post-treatment)

Booster Treatment

MC+B group receives 2 additional booster treatment sessions to review and reinforce learning and strategy use

1 month

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multicontext Approach

Trial Overview

The study tests a cognitive rehabilitation strategy called the Multicontext Approach, designed to help patients develop everyday strategies to manage cognitive deficits. It includes baseline testing, therapy sessions, and booster sessions for reinforcement.

How Is the Trial Designed?

Group I: MC Approach Experimental Treatment 1 Intervention

The experimental Multicontext Approach Intervention

Group II: MC + Booster Experimental Treatment 1 Intervention

From the MC Approach group only, MC+Boster participants will receive 2 additional treatment sessions with their original OT within the month following their 6mo FU assessment.

Group III: Process Training Active Control 1 Intervention

The Control Group cognitive process training

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40827856/

A Metacognitive Strategy Intervention for People With ...

In a pilot quasi-randomized controlled trial, we found that the MC Approach is feasible, safe, and acceptable for people with PwPD. We also ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07190404

Multicontext Approach for Cognitive Function in Parkinson ...

The MC Approach is a metacognitive strategy intervention that targets awareness, strategy use, and self-efficacy to improve functional cognitive ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999324001345

Effect of the Multicontext Approach on Functional Cognition ...

The Multicontext Approach improves self-rated performance of personalized functional cognitive goals among people with PD without dementia.

4.

research.aota.org

research.aota.org/ajot/article/78/Supplement_2/7811505015p1/25278/Participant-Engagement-amp-Effect-on-Functional

Participant Engagement & Effect on Functional Cognition of a ...

This pilot study supports the multicontext approach as feasible and effective for people with Parkinson disease without dementia.

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/09602011.2020.1810710

Feasibility and acceptability of the multicontext approach ...

The MC approach was associated with improvement in awareness, strategy use, and executive functioning at the conclusion of treatment. The MC approach may be a ...

6.

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 ...

In a pilot quasi-randomized controlled trial, we found that the MC Approach is feasible, safe, and acceptable for people with PwPD. We also ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9754996/

Design and validation of a multi-task, multi-context protocol ...

The protocol proved to be safe and feasible (all participants could complete it and no adverse events were recorded) and the addition of the more complex tasks ...