Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease (PDWM)
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| First Received Date ICMJE | July 13, 2012 | ||||||||||||||||||||||||
| Last Updated Date | July 19, 2012 | ||||||||||||||||||||||||
| Start Date ICMJE | October 2012 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01647698 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease | ||||||||||||||||||||||||
| Official Title ICMJE | Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease | ||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Parkinson Disease | ||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||||||||||||||||||
| Estimated Completion Date | October 2013 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT01647698 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | PDWM-2012-07 | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Capital District Health Authority, Canada | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Capital District Health Authority, Canada | ||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Capital District Health Authority, Canada | ||||||||||||||||||||||||
| Verification Date | July 2012 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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