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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01647698
First received: July 13, 2012
Last updated: September 24, 2014
Last verified: July 2012
  Purpose

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.


Condition Intervention
Parkinson Disease
Behavioral: Adaptive working memory training task
Behavioral: Non-adaptive working memory training task (i.e. an active control task)
Behavioral: No training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Baseline Working memory function [ Time Frame: baseline ] [ Designated as safety issue: No ]

    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 [ Time Frame: 5 weeks post training onset ] [ Designated as safety issue: No ]
  • Change in working memory function between baseline and 10 weeks post training onset [ Time Frame: 10 weeks post training onset ] [ Designated as safety issue: No ]
  • Change in working memory function between baseline and 22 weeks post training onset [ Time Frame: 22 weeks post training onset ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline fluid intelligence [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 weeks post training onset ] [ Designated as safety issue: No ]
  • Change in fluid intelligence between baseline and 10 weeks post training onset [ Time Frame: 10 weeks post training onset ] [ Designated as safety issue: No ]
  • Change in fluid intelligence between baseline and 22 weeks post training onset [ Time Frame: 22 weeks post training onset ] [ Designated as safety issue: No ]
  • Baseline Executive functioning [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 weeks post training onset ] [ Designated as safety issue: No ]
  • Change in executive functioning between baseline and 10 weeks post training onset [ Time Frame: 10 weeks post training onset ] [ Designated as safety issue: No ]
  • Change in executive function between baseline and 22 weeks post training onset [ Time Frame: 22 weeks post training onset ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early training group
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).
Behavioral: Adaptive working memory training task

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.

Behavioral: Non-adaptive working memory training task (i.e. an active control task)
Active control task will consist of a non-adaptive working memory task.
Experimental: Late training group
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.
Behavioral: Adaptive working memory training task

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.

Behavioral: Non-adaptive working memory training task (i.e. an active control task)
Active control task will consist of a non-adaptive working memory task.
Placebo Comparator: No training group
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.
Behavioral: No training
No training during the experiment.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647698

Contacts
Contact: Gail Eskes, PhD 19024943032 gail.eskes@dal.ca
Contact: Stephanie Jones, PhD 19024943033 stephaniejones03@hotmail.com

Locations
Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada
Contact: Gail Eskes, PhD    19024943032    gail.eskes@dal.ca   
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Study Director: Gail Eskes, PhD Dalhousie University
Study Chair: Raymond Klein, PhD Dalhousie University
Study Chair: David Westwood, PhD Dalhousie University
Principal Investigator: Stephanie Jones, PhD Dalhousie University
Principal Investigator: Greg McLean Dalhousie University
Principal Investigator: Janet Green, MA Dalhousie University
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01647698     History of Changes
Other Study ID Numbers: PDWM-2012-07
Study First Received: July 13, 2012
Last Updated: September 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
Parkinson Disease
near transfer
far transfer
working memory
fluid intelligence
cognitive training
dual n-back

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 27, 2014