Parkinson DiseasePDWMNCT01647698
Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease
A study testing Adaptive working memory training task and No training in people with Parkinson Disease, run by Gail Eskes at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Adaptive working memory training task and No training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Adaptive working memory training task, Non-adaptive working memory training task (i.e. an active control task), No training
- Keywords
- Parkinson Disease, near transfer, far transfer, working memory, fluid intelligence, cognitive training, dual n-back
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive working memory training taskBehavioural
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)Behavioural
Active control task will consist of a non-adaptive working memory task.
No trainingBehavioural
No training during the experiment.
| Study group | Role | What they receive |
|---|---|---|
| Early training group | Experimental | 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). Receives: Behavioral: Adaptive working memory training task; Behavioral: Non-adaptive working memory training task (i.e. an active control task) |
| Late training group | Experimental | 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. Receives: Behavioral: Adaptive working memory training task; Behavioral: Non-adaptive working memory training task (i.e. an active control task) |
| No training group | Placebo comparator | 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. Receives: Behavioral: No training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Change in working memory function between baseline and 5 weeks post training onset
Measured: 5 weeks post training onset
Change in working memory function between baseline and 10 weeks post training onset
Measured: 10 weeks post training onset
Change in working memory function between baseline and 22 weeks post training onset
Measured: 22 weeks post training onset
Secondary outcomes (8)
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.
Measured: Baseline
change in fluid intelligence between baseline and 5 weeks post training onset
Measured: 5 weeks post training onset
Change in fluid intelligence between baseline and 10 weeks post training onset
Measured: 10 weeks post training onset
Change in fluid intelligence between baseline and 22 weeks post training onset
Measured: 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.
Measured: Baseline
Change in executive functioning between baseline and 5 weeks post training onset
Measured: 5 weeks post training onset
Change in executive functioning between baseline and 10 weeks post training onset
Measured: 10 weeks post training onset
Change in executive function between baseline and 22 weeks post training onset
Measured: 22 weeks post training onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startOct 2013
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gail Eskes
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Gail Eskes, Nova Scotia Health Authority
- Investigators
- Gail Eskes, PhD, Study director, Dalhousie UniversityRaymond Klein, PhD, Study chair, Dalhousie UniversityDavid Westwood, PhD, Study chair, Dalhousie UniversityStephanie Jones, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647698
- Sponsor's protocol ID
- PDWM-2012-07
- Acronym
- PDWM
- Status last verified
- May 2023
- First submitted
- 13 Jul 2012
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01647698
- Acronym / sponsor ID
- PDWM / PDWM-2012-07
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, near transfer, far transfer, working memory, fluid intelligence, cognitive training, dual n-back
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gail EskesUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- Oct 2013 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early training group | Experimental | Behavioral: Adaptive working memory training task, Behavioral: Non-adaptive working memory training task (i.e. an active control task)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). |
| Late training group | Experimental | Behavioral: Adaptive working memory training task, Behavioral: Non-adaptive working memory training task (i.e. an 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. |
| No training group | Placebo comparator | Behavioral: No trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive working memory training taskThe 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. | Behavioural | Early training group, Late training group |
| Non-adaptive working memory training task (i.e. an active control task)Active control task will consist of a non-adaptive working memory task. | Behavioural | Early training group, Late training group |
| No trainingNo training during the experiment. | Behavioural | No training group |
Primary outcome
Baseline Working memory function
Time frame: baseline
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
Change in working memory function between baseline and 10 weeks post training onset
Time frame: 10 weeks post training onset
Change in working memory function between baseline and 22 weeks post training onset
Time frame: 22 weeks post training onset
8 secondary outcomes
Baseline fluid intelligence
Time frame: Baseline
change in fluid intelligence between baseline and 5 weeks post training onset
Time frame: 5 weeks post training onset
Change in fluid intelligence between baseline and 10 weeks post training onset
Time frame: 10 weeks post training onset
Change in fluid intelligence between baseline and 22 weeks post training onset
Time frame: 22 weeks post training onset
Baseline Executive functioning
Time frame: Baseline
Change in executive functioning between baseline and 5 weeks post training onset
Time frame: 5 weeks post training onset
Change in executive functioning between baseline and 10 weeks post training onset
Time frame: 10 weeks post training onset
Change in executive function between baseline and 22 weeks post training onset
Time frame: 22 weeks post training onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Eskes, PhD study director
Dalhousie University
Raymond Klein, PhD study chair
Dalhousie University
David Westwood, PhD study chair
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive working memory training task and No training in people with Parkinson Disease, run by Gail Eskes at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Working memory function (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.