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NCT04048122 · ClinicalTrials.gov registry record · NA

Feasibility and Effect of a Strategy-Based Cognitive Intervention for Parkinson Disease

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
57
Enrollment target

NCT04048122: Completed NA study, sponsored by Washington University School of Medicine.

NCT04048122 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04048122, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
57 participants
Enrollment target

Study 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

Primary Outcome

BGSI is a structured interview schedule was used to record participant ratings of performance and satisfaction in reaching specific goals, and to record additional ratings of goal attainment. This instrument rates goal attainment on a ten point scale (1-10) with a higher score indicating higher goal attainment.

Interventions

  • BEHAVIORAL Standard of Care
  • BEHAVIORAL MultiContext for PD Strategy Training

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2019-11-04
Est. Completion 2022-07-01
Phase NA

What the finished NCT04048122 record still lists

NCT04048122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.

NCT04048122 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04048122 about?

NCT04048122 is a clinical study titled "Feasibility and Effect of a Strategy-Based Cognitive Intervention for Parkinson Disease". 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. Su...

What is the current status of trial NCT04048122?

This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2019-11-04. Estimated completion is 2022-07-01.

What interventions are being tested in trial NCT04048122?

The interventions under investigation include: Standard of Care (BEHAVIORAL), MultiContext for PD Strategy Training (BEHAVIORAL).

Who is sponsoring clinical trial NCT04048122?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04048122's enrollment target sits among peer trials

57 1261st of 2000 higher than 739 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04048122, the US trial registry maintained by the National Library of Medicine. NCT04048122 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.