Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease

Parkinson Disease Clinical Trial

— FOCI-PD  

Official title:

Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826785
• Other study ID #: 201403072
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates the feasibility of a cognitive strategy training intervention for people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire study duration per participant = 8 weeks). We will measure participant responsiveness and the overall efficiency of the intervention process.

Description:

Cognitive impairment is common in Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Existing rehabilitative interventions, which focus on cognitive process training, have not been successful in mitigating its negative functional consequences. We have developed a client-centered cognitive strategy training intervention to enable people with PD to work around their cognitive deficits and maintain their functional performance. This study is an exploratory case series to assess aspects of its feasibility. Specifically, we will assess participant responsiveness to the intervention (acceptance, engagement, adherence), and we will track logistical information (e.g., scheduling). We will also administer an exploratory outcome measure of treatment effect to gain preliminary evidence on the effect of the intervention on self-identified cognitive performance problems. This information will guide modifications and enhancements in preparation for future clinical trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn & Yahr stage I-III (mild to moderate disease; Hoehn & Yahr, 1967) and are treated with levodopa/carbidopa. For this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it.

Exclusion Criteria:

• Possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., STN DBS), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-English speaking). Participants taking benzos will be excluded.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Cognitive strategy training
The intervention teaches strategies in a way that promotes generalization and enhances daily function . It includes four core elements known to enhance learning transfer: (1) self-generation of broadly applicable strategies, (2) practice across multiple contexts and activities, (3) emphasis on metacognition, and (4) use of meaningful everyday activities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client Satisfaction Questionnaire		8 weeks