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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01647698
Other study ID # PDWM-2012-07
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Dalhousie University Halifax Nova Scotia

Sponsors (2)

Lead Sponsor Collaborator
Gail Eskes Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
baseline
Primary Change in working memory function between baseline and 5 weeks post training onset 5 weeks post training onset
Primary Change in working memory function between baseline and 10 weeks post training onset 10 weeks post training onset
Primary Change in working memory function between baseline and 22 weeks post training onset 22 weeks post training onset
Secondary 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. Baseline
Secondary change in fluid intelligence between baseline and 5 weeks post training onset 5 weeks post training onset
Secondary Change in fluid intelligence between baseline and 10 weeks post training onset 10 weeks post training onset
Secondary Change in fluid intelligence between baseline and 22 weeks post training onset 22 weeks post training onset
Secondary 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. Baseline
Secondary Change in executive functioning between baseline and 5 weeks post training onset 5 weeks post training onset
Secondary Change in executive functioning between baseline and 10 weeks post training onset 10 weeks post training onset
Secondary Change in executive function between baseline and 22 weeks post training onset 22 weeks post training onset
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