Clinical trial NCT01647698: Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease
Official title: Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
near transfer
far transfer
working memory
fluid intelligence
cognitive training
dual n-back
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2012-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Baseline Working memory function
timeFrame: baseline
measure: Change in working memory function between baseline and 5 weeks post training onset
timeFrame: 5 weeks post training onset
measure: Change in working memory function between baseline and 10 weeks post training onset
timeFrame: 10 weeks post training onset
measure: Change in working memory function between baseline and 22 weeks post training onset
timeFrame: 22 weeks post training onset
Secondary outcomes:
measure: Baseline fluid intelligence
timeFrame: Baseline
measure: change in fluid intelligence between baseline and 5 weeks post training onset
timeFrame: 5 weeks post training onset
measure: Change in fluid intelligence between baseline and 10 weeks post training onset
timeFrame: 10 weeks post training onset
measure: Change in fluid intelligence between baseline and 22 weeks post training onset
timeFrame: 22 weeks post training onset
measure: Baseline Executive functioning
timeFrame: Baseline
measure: Change in executive functioning between baseline and 5 weeks post training onset
timeFrame: 5 weeks post training onset
measure: Change in executive functioning between baseline and 10 weeks post training onset
timeFrame: 10 weeks post training onset
measure: Change in executive function between baseline and 22 weeks post training onset
timeFrame: 22 weeks post training onset
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Gail Eskes, PhD
role: STUDY_DIRECTOR
affiliation: Dalhousie University
name: Raymond Klein, PhD
role: STUDY_CHAIR
affiliation: Dalhousie University
name: David Westwood, PhD
role: STUDY_CHAIR
affiliation: Dalhousie University
name: Stephanie Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: