N/A
N=57
Feasibility and Effect of a Strategy-Based Cognitive Intervention for Parkinson Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04048122 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Oct 2023
Primary outcome: Primary: Change in Bangor Goal Setting Interview (BGSI) Goal Attainment — 4.5; 4.6; 5.9; 7.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MultiContext for PD Strategy Training (Behavioral); Standard of Care (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bangor Goal Setting Interview (BGSI) Goal Attainment |
4.5; 4.6; 5.9; 7.4; 5.6; 6.9 | — |
| SECONDARY Client Satisfaction Questionnaire |
28.8; 29.3 | — |
| SECONDARY Treatment Fidelity Scale |
1.0; 1.8; 1.0; 1.8; 1.1; 1.9 | — |
Summary
Parkinson disease (PD) affects over 1 million Americans and causes considerable personal and socioeconomic costs (>$34 billion/year in the US) that are expected to rise as the population ages. Cognitive impairment produces disability and reduced quality of life among non-demented people with PD. Surgical and pharmacologic treatments for PD do not prevent or treat cognitive impairment and may even exacerbate the problem. As such, cognitive rehabilitation treatments that mitigate its negative functional consequences are a top research priority.
Unfortunately, existing cognitive rehabilitative programs for PD, which focus on restoring deficient cognitive processes through process training (repetitive practice of tasks that challenge specific cognitive processes), have had limited effect on daily function. To overcome this limitation, the investigators take a strategy training approach. Trained occupational therapists teach people targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish meaningful daily activities. Contemporary cognitive rehabilitation evidence supports this approach for people with chronic neurocognitive dysfunction from stroke and brain injury; however, it has not been studied in PD. By teaching strategies for everyday cognition and using training techniques to support transfer of learning beyond the training context, the investigators hypothesize that our strategy training interventions will produce better functional outcomes for people with PD compared to process training.
The investigators developed MultiContext for PD (MC4PD) to enable people with PD to apply strategies in their everyday lives to cope with cognitive decline and improve or maintain daily function. MC4PD is an individualized, community-based intervention that focuses on the attainment of personally meaningful functional goals using training techniques known to enhance strategy learning and transfer. In an iterative case series, the investigators fine-tuned the treatment protocol, established good participant acceptance and engagement, and provided preliminary data on its benefits for daily cognitive function. The next step is to confirm MC4PD's feasibility in a randomized controlled trial (RCT). In this project, the investigators will assess feasibility and treatment fidelity and generate data in preparation for a definitive RCT by conducting a single-blind pilot RCT comparing MC4PD to a standard-of-care treatment (Control). Individuals with PD will complete pre-treatment testing, randomization to treatment group, 10 treatment sessions, and immediate and 3 months post-treatment testing.
Eligibility Criteria
Inclusion Criteria
- males and females over age 40 who meet criteria for typical idiopathic PD (stage I-III)
- Have subjective cognitive decline (SCD) as defined by a positive answer to either question: "Do you feel like your thinking skills or memory are becoming worse?" "Do you have problems with your thinking skills or memory?", and can list one or more daily cognitive challenge they wish to address.
- Medications should be stable for 4 weeks prior with no changes planned during the study (we will document unplanned changes).
Exclusion Criteria
- Dementia according to MDS criteria or a Montreal Cognitive Assessment (MoCA) score < 21
- other neurological disorders
- brain surgery
- history of psychotic disorder
- any condition that would interfere with participation (e.g. non-English speaking, significant current depression)
Data sourced from ClinicalTrials.gov (NCT04048122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.