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Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease (PDWM)

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adaptive working memory training task
Non-adaptive working memory training task (i.e. an active control task)
No training
Sponsored by
Gail Eskes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, near transfer, far transfer, working memory, fluid intelligence, cognitive training, dual n-back

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of idiopathic Parkinson's disease
  • self-reported concerns about their working memory, or working memory deficits that were identified by a clinical examination
  • be classified as Hohn & Yahr Stage 1 or 2
  • be receiving a stable dose of dopaminergic therapy

Exclusion Criteria:

  • presence of dementia or other significant neurological or psychiatric conditions, as determined by clinical history
  • Classification as Hohm & Yahr Stage 3 or 4
  • Not on a stable dos of dopaminergic therapy

Sites / Locations

  • Dalhousie University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Early training group

Late training group

No training group

Arm Description

The early training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. They will continue training on the adaptive working memory training task for 5 weeks, after which they will continue for 5 weeks using a non-adaptive working memory task (active control task).

The late training group will consist of 10 randomly assigned participants who will engage in a non-adaptive working memory training task (i.e. an active control task) immediately after baseline assessment for 5 weeks. After the initial 5 weeks of the active control task they will then switch to the adaptive working memory task (the intervention) for 5 weeks. This is a randomized controlled cross-over design.

The no training group will engage in no training over the course of the pilot study, but will still participate in baseline, 5 week, 10 . This will allow us to determine if changes in the outcome and assessment variables are due to the working memory training or progression in the disease itself.

Outcomes

Primary Outcome Measures

Baseline Working memory function
Working memory will be measured using the operation span task, the symmetry span task and the Sternberg memory scanning tasks. Operation span - This is a dual-task in which participants complete mathematical reasoning (e.g. solving a mathematical equation) while using short-term verbal memory to remember words. Symmetry span: This is a dual task in which participants discriminate about the symmetry of visual stimuli while using short-term spatial memory to remember the locations of stimuli. Sternberg memory scanning task - number memory test
Change in working memory function between baseline and 5 weeks post training onset
Change in working memory function between baseline and 10 weeks post training onset
Change in working memory function between baseline and 22 weeks post training onset

Secondary Outcome Measures

Baseline fluid intelligence
Fluid intelligence will be measured using Cattell's Culture Fair Intelligence Test, a measure of analogical reasoning, and Raven's Progressive Matrices, a measure of spatial reasoning.
change in fluid intelligence between baseline and 5 weeks post training onset
Change in fluid intelligence between baseline and 10 weeks post training onset
Change in fluid intelligence between baseline and 22 weeks post training onset
Baseline Executive functioning
Executive functioning will be measured using the Dysexecutive Questionnaire. It is a self-report and other-report of everyday behaviours reflecting executive function.
Change in executive functioning between baseline and 5 weeks post training onset
Change in executive functioning between baseline and 10 weeks post training onset
Change in executive function between baseline and 22 weeks post training onset

Full Information

First Posted
July 13, 2012
Last Updated
May 18, 2023
Sponsor
Gail Eskes
Collaborators
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01647698
Brief Title
Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease
Acronym
PDWM
Official Title
Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gail Eskes
Collaborators
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project will investigate the feasibility and preliminary effectiveness of an intensive and focused working memory training program for patients in the early stages of PD receiving dopaminergic therapy. The investigators hypothesize that working memory training will be an effective method of improving working memory and related cognitive and behavioural functions in PD patients.
Detailed Description
Parkinson's disease (PD) is not an exclusively motor disease; more than half of individuals with PD experience cognitive impairment even in the early stages of the disease and many develop dementia as the disease progresses. As a result, attention, memory, planning and organizational skills can be affected, interfering with everyday functioning (e.g. shopping, managing finances, job skills). Thus, interventions to improve cognitive abilities are needed to enhance psychosocial function and overall quality of life. Some cognitive deficits, such as problems with working memory, are apparent even in the early stages of the disease. Working memory (WM) is the ability to actively maintain and manipulate information in one's mind and is needed for many complex tasks such as learning, communication and problem-solving . Individuals with PD often show deficits in both WM maintenance (e.g., holding a phone number in mind to make a call) and manipulation (e.g.,mental calculation at the grocery store checkout) skills, depending upon the stage of the disease and progression of damage to frontal-subcortical circuits. Attempts to identify pharmacological agents that ameliorate cognitive dysfunction have been largely unsuccessful or associated with undesirable side effects (e.g. Vale, 2009). The investigators propose that specific cognitive training to improve WM could provide direct benefit to psychosocial function of PD patients; it could potentially enhance any positive benefits or reduce the negative effects of pharmacological treatment without an added risk of side effects as well. Promising interventions focused on intensive and direct WM training are emerging and have been shown to generalize to other cognitive domains, such as fluid intelligence. Cognitive training has been successful in patients with traumatic brain injury, who also show WM deficits as a result of damage to frontal-subcortical circuits. In addition, successful WM training is associated with changes in dopamine receptor density as well as changes in patterns of neural activity in task-relevant areas of the brain. To date, a limited number of small group studies provide preliminary evidence that some aspects of cognitive function can be enhanced by training in PD patients also receiving dopaminergic therapy, although few use control groups to account for potential repeated testing practice effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, near transfer, far transfer, working memory, fluid intelligence, cognitive training, dual n-back

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early training group
Arm Type
Experimental
Arm Description
The early training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. They will continue training on the adaptive working memory training task for 5 weeks, after which they will continue for 5 weeks using a non-adaptive working memory task (active control task).
Arm Title
Late training group
Arm Type
Experimental
Arm Description
The late training group will consist of 10 randomly assigned participants who will engage in a non-adaptive working memory training task (i.e. an active control task) immediately after baseline assessment for 5 weeks. After the initial 5 weeks of the active control task they will then switch to the adaptive working memory task (the intervention) for 5 weeks. This is a randomized controlled cross-over design.
Arm Title
No training group
Arm Type
Placebo Comparator
Arm Description
The no training group will engage in no training over the course of the pilot study, but will still participate in baseline, 5 week, 10 . This will allow us to determine if changes in the outcome and assessment variables are due to the working memory training or progression in the disease itself.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive working memory training task
Intervention Description
The working memory training task will consist of an adaptive working memory computer program that will test and extend patients' working memory capacity. Adaptive refers to the increase in the number of items that the patient is required to remember.
Intervention Type
Behavioral
Intervention Name(s)
Non-adaptive working memory training task (i.e. an active control task)
Intervention Description
Active control task will consist of a non-adaptive working memory task.
Intervention Type
Behavioral
Intervention Name(s)
No training
Intervention Description
No training during the experiment.
Primary Outcome Measure Information:
Title
Baseline Working memory function
Description
Working memory will be measured using the operation span task, the symmetry span task and the Sternberg memory scanning tasks. Operation span - This is a dual-task in which participants complete mathematical reasoning (e.g. solving a mathematical equation) while using short-term verbal memory to remember words. Symmetry span: This is a dual task in which participants discriminate about the symmetry of visual stimuli while using short-term spatial memory to remember the locations of stimuli. Sternberg memory scanning task - number memory test
Time Frame
baseline
Title
Change in working memory function between baseline and 5 weeks post training onset
Time Frame
5 weeks post training onset
Title
Change in working memory function between baseline and 10 weeks post training onset
Time Frame
10 weeks post training onset
Title
Change in working memory function between baseline and 22 weeks post training onset
Time Frame
22 weeks post training onset
Secondary Outcome Measure Information:
Title
Baseline fluid intelligence
Description
Fluid intelligence will be measured using Cattell's Culture Fair Intelligence Test, a measure of analogical reasoning, and Raven's Progressive Matrices, a measure of spatial reasoning.
Time Frame
Baseline
Title
change in fluid intelligence between baseline and 5 weeks post training onset
Time Frame
5 weeks post training onset
Title
Change in fluid intelligence between baseline and 10 weeks post training onset
Time Frame
10 weeks post training onset
Title
Change in fluid intelligence between baseline and 22 weeks post training onset
Time Frame
22 weeks post training onset
Title
Baseline Executive functioning
Description
Executive functioning will be measured using the Dysexecutive Questionnaire. It is a self-report and other-report of everyday behaviours reflecting executive function.
Time Frame
Baseline
Title
Change in executive functioning between baseline and 5 weeks post training onset
Time Frame
5 weeks post training onset
Title
Change in executive functioning between baseline and 10 weeks post training onset
Time Frame
10 weeks post training onset
Title
Change in executive function between baseline and 22 weeks post training onset
Time Frame
22 weeks post training onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of idiopathic Parkinson's disease self-reported concerns about their working memory, or working memory deficits that were identified by a clinical examination be classified as Hohn & Yahr Stage 1 or 2 be receiving a stable dose of dopaminergic therapy Exclusion Criteria: presence of dementia or other significant neurological or psychiatric conditions, as determined by clinical history Classification as Hohm & Yahr Stage 3 or 4 Not on a stable dos of dopaminergic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Eskes, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raymond Klein, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Westwood, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephanie Jones, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

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Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease

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