Parkinson DiseaseiPARKNCT03680170
Cognitive Training in Parkinson's Disease, the iPARK Study
A study testing Working memory updating training in people with Parkinson Disease and Cognitive Impairment, run by Umeå University at 1 site in Sweden.
Trial summary
The aim of the iPARK-study is to investigate the effects of a process-based cognitive training program with focus on working memory in patients with Parkinson's Disease (PD). The study is a double blinded, randomized controlled trial with a parallel group design that aim to recruit 80 persons with PD. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease, Cognitive Impairment
- What is being tested?
- Working memory updating training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 1 Feb 2023
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's Disease according to United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria
- Hoehn and Yahr stage I-III
- Pathological dat scan
- A score of 24 or over on the MMSE AND be without Dementia
- Stable medication over the past three months
- Owns and is able to use a home based computer or tablet with internet connection.
Who cannot join
- Unstable medication
- Ongoing cognitive training
- Diagnosis of PDD
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Umeå University department of psychology
Umeå, Västerbotten County, 90187
Magdalena E Domellöf, Phd, +46907867022, magdalena.domellof@umu.se
Anna Stigsdotter Neely, Prof, +46547001545, anna.neely@kau.se
About this study
Official title: The Effect of Home-based Working Memory Updating Training on Cognition and Health in Patients With Parkinson's Disease
The aim of the iPARK-study is to investigate the effects of a process-based cognitive training program with focus on working memory in patients with Parkinson's Disease (PD). The study is a double blinded, randomized controlled trial with a parallel group design that aim to recruit 80 persons with PD. All patients will undergo 30 sessions (6-7 weeks) of web-based cognitive training performed at home. The working memory training is a process-based training program focusing specific on updating. The placebo program is a low dose short term memory paradigm without updating. A battery of neuropsychological tests (working memory, attention, episodic memory, inhibition control, risk taking and motoric speed) and questionnaires (everyday functioning and psychological health) will be performed before training and directly after training and after 16 weeks. Patient expectation and measures of adherence (motivation and results during training) will be controlled for.
The iPARK trial is expected to provide novel and clinical useful information whether updating training is an effective training paradigm in PD. Further it will hopefully contribute to a better understanding of cognitive function in PD.
Read the detailed description
Parkinson's Disease (PD) is after Alzheimers disease (AD) the most common neurodegenerative disease with a prevalence of 1% of the population over 60 years of age. The cardinal symptoms are motoric and are believed to be caused by depletion of dopamine in the brain with severe depletion in the striatum. In addition to the motor impairments, there are several non-motor functions also affected, where cognitive decline and dementia are among the most common problems. Some claim that up to 75% of the total PD population will eventually develop dementia. Prior to dementia, milder cognitive problems are common and already at the time of diagnosis up to 42.5% of patients with PD are affected by decline in different cognitive functions. Early cognitive deficits seen is inhibition, shifting, working memory and planning, but a cognitive profile of visuospatial decline, semantic fluency and episodic memory has been connected to Parkinson's Disease Dementia (PDD). The occurrence of Lewy-bodies and Alzheimer type brain pathology is common in PDD but dopamine depletion has also been connected to cognitive decline in healthy elderly and in PD.
Although prescription of dementia medication in PD most likely has increased during the last decade there are limited evidence of treatment effects . This particular patient group is already burdened by polypharmacy and therefore investigating non-pharmacological interventions is of crucial importance. A recent systematic review of cognitive intervention studies in PD suggests that there is evidence of clinically meaningful improvements in overall cognition and moderate to large effect sizes on measures of working memory, processing speed and executive functions. Another review on the topic suggested that the results are promising, at least in the immediate or short term for some cognitive domains, but due to inconsistencies between studies and lack of methodological salience there are still a lot of questions unanswered. Baseline factors such as cognitive functioning, Hoehn and Yahr stage, premorbid intelligence all can have contributing effects on individual differences in training gain. Therefore it is important to thoroughly investigate baseline characteristics.
In the future, studies need to include more participants, be hypothesis driven and include more detail of the cognitive profile, training intervention and outcome measures.
One approach to cognitive training that has received a lot of attention and critique is process-based cognitive training, such as training focusing on working memory (WM) and executive functions (EF). The purpose of the process based approach is to strengthen general cognitive processes important to global cognitive functioning. WM and EF play central roles in several different functions such as episodic memory, reading comprehension and problem solving to mention a few. Research has also shown that WM and EF is negatively affected both in normal and pathological aging, such as PD.
Training of executive functioning and working memory have gained some promising results in healthy adults, showing improvements in working memory and executive functioning but there is also an indication of broader generalizations of training gain. Previously the effect of process-based updating training in healthy young and older individuals has been studied. Results showed that a period of updating training increased Blood Oxygen Level Dependent (BOLD) activity in striatum related to increased cognitive performance in both groups. Also a corresponding effect of training on dopaminergic neurotransmission was detected.
In the light of the dopamine dysfunction in PD, with negative effects on both motoric and cognitive function it is of interest to study if a non-invasive, non-pharmacological intervention can lead to better updating function with increased dopamine levels in patients with PD. The iPARK study is a double blinded randomized controlled trial that will examine the effect of a web-based cognitive training program with focus on updating training.
The primary question asked will be if updating training will improve the ability to update contents in working memory and also if there will be improvements in other cognitive functions such as psychomotor speed, working memory, executive functions and episodic memory. Further the aim is to investigate if there will be improvements in self-perceived everyday cognitive function and psychological health as well as if the effects seen will be sustained over a period of four months. Baseline factors will be investigated to see if they have a modulating effect on training. Further the iPARK trial will determine if a web-based training performed at home without active supervision is a feasible approach in this particular patient group. Compliance, adherence and expectations will be measured systematically.
- Conditions
- Parkinson Disease, Cognitive Impairment
- Being tested
- Working memory updating training, Placebo training
- Keywords
- Cognitive rehabilitation, Working memory, Randomized controlled trial, Placebo control
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory updating trainingBehavioural
Also called Web-based, Computer-based training, Internet-based training
Each training session includes four working memory updating tasks that is performed at the participants home on their computer via internet. Each training session takes about 20 minutes to perform.
Placebo trainingBehavioural
Also called Web-based training, Computer-based training, Internet-based training
Each training session includes four short term memory tasks that is performed at the participants home on their computer via internet. Each training session takes about 20 minutes to perform.
| Study group | Role | What they receive |
|---|---|---|
| Working memory updating training | Experimental | Training with web-based program on the internet for 30 sessions (4-5 times a week). The result of the training is registered.
Intervention Device: web-based cognitive training Receives: Behavioral: Working memory updating training |
| Placebo training | Placebo comparator | Low dose, short term memory training. Intervention: Training with computer based program on the internet for 30 sessions (4-5 times a week).
Intervention Device: Web-based cognitive training Receives: Behavioral: Placebo training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Criterion task
Improvement on Letter memory after 30 sessions of working memory training. total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Criterion task
Maintenance of Letter memory performance four months after completed working memory training.
total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Secondary outcomes (30)
Transfer task n-back
Improvement on updating performance measured by n-back (1,2 and 3 back) after 30 sessions of working memory training.
- back total score: 0-90 higher score indicate better performance
- back total score: 0-90 higher score indicate better performance
- back total score: 0-90 higher score indicate better performance
1 back, Yes minus false alarms: 0-36 higher score indicate better performance 2 back, Yes minus false alarms: 0-36 higher score indicate better performance 3 back, Yes minus false alarms: 0-36 higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task n-back
Maintenance of updating performance measured by n-back (1,2 and 3 back) four months after completed working memory training.
- back total score: 0-90 higher score indicate better performance
- back total score: 0-90 higher score indicate better performance
- back total score: 0-90 higher score indicate better performance
1 back, Yes minus false alarms: 0-36 higher score indicate better performance 2 back, Yes minus false alarms: 0-36 higher score indicate better performance 3 back, Yes minus false alarms: 0-36 higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task digit memory running span
Improvement on updating performance measured by digit memory running span after 30 sessions of working memory training.
total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task digit memory running span
Maintenance of updating performance measured by digit memory running span four months after completed working memory training.
total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Updating total score
Improvement in calculated composite score based on z-score((raw test score-mean of group)/standard deviation of group) for digit memory running span, 2-back and 3-back. Range -4 to 4. Higher z-score indicate better updating performance.
(z score(3back yes-false alarms)+z score(2back yes-false alarms)+z score (digit memory running span total))/3
Measured: 6-8 weeks (pretest-posttest 1)
Updating total score
Maintenance of calculated composite score based on z-score((raw test score-mean of group)/standard deviation of group) for digit memory running span, 2-back and 3-back. Range -4 to 4. Higher z-score indicate better updating performance.
(z score(3back yes-false alarms)+z score(2back yes-false alarms)+z score (digit memory running span total))/3
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task episodic memory
Improvement on episodic memory performance measured by Buschke Selective Reminding Procedure after 30 sessions of working memory training.
total score: 0-74 higher score indicate better performance list learning: 0-74 delayed score:0-18 higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task episodic memory
Maintenance of on episodic memory performance measured by Buschke Selective Reminding Procedure four months after completed working memory training.
total score: 0-74 higher score indicate better performance list learning: 0-74 higher score indicate better performance delayed score:0-18 higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task digit span
Improvement on working memory performance measured by Digit span forward, backwards and sequencing (WAIS IV) after 30 sessions of working memory training.
digit span forward total score: 0-16 higher score indicate better performance digit span backwards total score: 0-16 higher score indicate better performance digit span sequencing total score:0-16 higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task digit span
Maintenance of working memory performance measured by Digit span forward, backwards and sequencing (WAIS IV) after 30 sessions of working memory training.
digit span forward total score: 0-16 higher score indicate better performance digit span backwards total score: 0-16 higher score indicate better performance digit span sequencing total score:0-16 higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task visuospatial-span
Maintenance of visuospatial working memory performance measured by visuospatial span task, 0-18 higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task visuospatial-span
Maintenance of visuospatial working memory performance measured by visuospatial span task, total score 0-18 higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
working memory total score
Improvement in calculated composite score based on z-score((raw test score-mean of group)/standard deviation of group) from digit span forward, digit span backward, digit span sequencing and visuospatial span task, higher score indicate better performance Range -4 to 4.
(z score(digit span forward)+z score(digit span backward)+z score (digit span sequencing)+z score (visuospatial span task))/4
Measured: 6-8 weeks (pretest-posttest 1)
working memory total score
Maintenance in calculated composite score based on z-score((raw test score-mean of group)/standard deviation of group) from digit span forward, digit span backward, digit span sequencing and visuospatial span task, higher score indicate better performance. Range -4 to 4.
(z score(digit span forward)+z score(digit span backward)+z score (digit span sequencing)+z score (visuospatial span task))/4
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task Matrices (WAIS IV)
Improvement on problem solving performance measured by Matrices (WAIS IV) after 30 sessions of working memory training.
total score: 0-26, higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task Matrices (WAIS IV)
Maintenance of problem solving performance measured by Matrices (WAIS IV) after 30 sessions of working memory training.
total score: 0-26, higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task Digit symbol
Improvement on mental and psychomotor speed measured by Digit symbol after 30 sessions of working memory training.
total score: 0-135, higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task Digit symbol
Maintenance of mental and psychomotor speed measured by Digit symbol four months after completed working memory training.
total score: 0-135, higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task Perdue pegboard
Improvement in calculated mental and psychomotor speed measured by Perdue pegboard after 30 sessions of working memory training.
total score right hand: 0-24, higher score indicate better performance total score left hand: 0-24 higher score indicate better performance total score both hands: 0-24higher score indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task Perdue pegboard
Maintenance of mental and psychomotor speed measured by Perdue pegboard four months after completed working memory training.
total score right hand: 0-24, higher score indicate better performance total score left hand: 0-24 higher score indicate better performance total score both hands: 0-24higher score indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Mental and psychomotor speed total score
Improvement in calculated composite score based on z-score((raw test score-mean of group)/standard deviation of group) for Digit symbol and Perdue pegboard after 30 sessions of working memory training. higher score indicate better performance (range -4 to 4).
(z score(Perdue pegboard)+z score(digit symbol))/2
Measured: 6-8 weeks (pretest-posttest 1)
Mental and psychomotor speed total score
Maintenance of calculated composite score based on z-score((raw test score-mean of group)/standard deviation of group) from Digit symbol and Perdue pegboard four months after completed working memory training. higher score indicate better performance. (range -4 to 4).
(z score(Perdue pegboard)+z score(digit symbol))/2
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task Stroop test
Improvement of executive functions measured by Stroop test (DKEFS) after 30 sessions of working memory training.
color naming 0-90 seconds less time indicate better performance word naming 0-90 seconds less time indicate better performance inhibition 0-90 seconds less time indicate better performance Inhibition cost total score:0-90 seconds, less inhibition cost indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task Stroop test
Maintenance of executive functions measured by Stroop test (DKEFS) four months after completed working memory training.
color naming 0-90 seconds less time indicate better performance word naming 0-90 seconds less time indicate better performance inhibition 0-90 seconds less time indicate better performance Inhibition cost total score:0-90 seconds, less inhibition cost indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task Trail Making Test
Improvement on executive functions measured by Trail Making Test A and B (DKEFS) after 30 sessions of working memory training.
TMT A 0-250 seconds less time indicate better performance TMT B 0-350 seconds less time indicate better performance Shift cost (TMTB-TMTA): 0-200 seconds, less shift cost indicate better performance
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task Trail Making Test
Maintenance of executive functions measured by Trail Making Test A and B (DKEFS) four months after completed working memory training.
TMT A 0-250 seconds less time indicate better performance TMT B 0-350 seconds less time indicate better performance Shift cost (TMTB-TMTA): 0-200 seconds, less shift cost indicate better performance
Measured: 16 weeks (posttest 1-posttest 2)
Executive function total score
Improvement calculated composite score based on z-score((raw test score-mean of group)/standard deviation of group) of Stroop test and Trail Making Test A and B after 30 sessions of working memory training higher score indicate better performance. Range -4 to 4.
(z score(-TMTB-TMTA)+z score(-inhibition cost))/2
Measured: 6-8 weeks (pretest-posttest 1)
Executive function total score
Maintenance of calculated z-score ((raw test score-mean of group)/standard deviation of group) of Stroop test and Trail Making Test A and B after 30 sessions of working memory training higher score indicate better performance. Range -4 to 4.
(z score(-TMTB-TMTA)+z score(-inhibition cost))/2
Measured: 16 weeks (posttest 1-posttest 2)
Transfer task subjective cognitive complaints
Improvement on subjective memory complaints measured by Prospective retrospective memory questionaire after 30 sessions of working memory training.
total score: 16-80 higher scores indicate more cognitive complaints prospective score: 0-100 higher scores indicate more cognitive complaints retrospective score: 0-100 higher scores indicate more cognitive complaints short term score: 0-100 higher scores indicate more cognitive complaints long term score: 0-100 higher scores indicate more cognitive complaints self cued score: 0-100 higher scores indicate more cognitive complaints environmentally cued: 0-100 higher scores indicate more cognitive complaints
Measured: 6-8 weeks (pretest-posttest 1)
Transfer task subjective cognitive complaints
Maintenance of subjective memory complaints measured by Prospective retrospective memory questionaire four months after completed working memory training.total score: 16-80 higher scores indicate more cognitive complaints prospective score: 0-100 higher scores indicate more cognitive complaints retrospective score: 0-100 higher scores indicate more cognitive complaints short term score: 0-100 higher scores indicate more cognitive complaints long term score: 0-100 higher scores indicate more cognitive complaints self cued score: 0-100 higher scores indicate more cognitive complaints environmentally cued: 0-100 higher scores indicate more cognitive complaints
Measured: 16 weeks (posttest 1-posttest 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Feb 2017
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Two parallel assigned intervention groups with randomized allocation.The intervention of focus is a web-based working memory updating training. The placebo condition consists of a web-based low dose short term memory training. Both groups received pretesting (pre-test) before 30 sessions (6-8 weeks) of training followed by immediate post-testing (post-test 1) and a long term follow up four months after training (post-test 2)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Karlstad University
- Responsible party
- Principal investigator, Anna Stigsdotter Neely, Umeå University
- Investigators
- Anna S Neely, Prof, Principal investigator, Karlstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680170
- Sponsor's protocol ID
- dnr 2014-1654
- Other IDs
- dnr 2017-02371
- Acronym
- iPARK
- Status last verified
- Jun 2021
- First submitted
- 20 Apr 2018
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
PubMed 16713924Aarsland D, Kurz MW. The epidemiology of dementia associated with Parkinson disease. J Neurol Sci. 2010 Feb 15;289(1-2):18-22. doi: 10.1016/j.jns.2009.08.034. Epub 2009 Sep 4.
PubMed 19733364Elgh E, Domellof M, Linder J, Edstrom M, Stenlund H, Forsgren L. Cognitive function in early Parkinson's disease: a population-based study. Eur J Neurol. 2009 Dec;16(12):1278-84. doi: 10.1111/j.1468-1331.2009.02707.x. Epub 2009 Jun 15.
PubMed 19538208Yarnall AJ, Breen DP, Duncan GW, Khoo TK, Coleman SY, Firbank MJ, Nombela C, Winder-Rhodes S, Evans JR, Rowe JB, Mollenhauer B, Kruse N, Hudson G, Chinnery PF, O'Brien JT, Robbins TW, Wesnes K, Brooks DJ, Barker RA, Burn DJ; ICICLE-PD Study Group. Characterizing mild cognitive impairment in incident Parkinson disease: the ICICLE-PD study. Neurology. 2014 Jan 28;82(4):308-16. doi: 10.1212/WNL.0000000000000066. Epub 2013 Dec 20.
PubMed 24363137Kehagia AA, Barker RA, Robbins TW. Neuropsychological and clinical heterogeneity of cognitive impairment and dementia in patients with Parkinson's disease. Lancet Neurol. 2010 Dec;9(12):1200-1213. doi: 10.1016/S1474-4422(10)70212-X. Epub 2010 Sep 27.
PubMed 20880750Landau SM, Lal R, O'Neil JP, Baker S, Jagust WJ. Striatal dopamine and working memory. Cereb Cortex. 2009 Feb;19(2):445-54. doi: 10.1093/cercor/bhn095. Epub 2008 Jun 11.
PubMed 18550595Ekman U, Eriksson J, Forsgren L, Mo SJ, Riklund K, Nyberg L. Functional brain activity and presynaptic dopamine uptake in patients with Parkinson's disease and mild cognitive impairment: a cross-sectional study. Lancet Neurol. 2012 Aug;11(8):679-87. doi: 10.1016/S1474-4422(12)70138-2. Epub 2012 Jun 27.
PubMed 22742929Ito K, Nagano-Saito A, Kato T, Arahata Y, Nakamura A, Kawasumi Y, Hatano K, Abe Y, Yamada T, Kachi T, Brooks DJ. Striatal and extrastriatal dysfunction in Parkinson's disease with dementia: a 6-[18F]fluoro-L-dopa PET study. Brain. 2002 Jun;125(Pt 6):1358-65. doi: 10.1093/brain/awf134.
PubMed 12023324Seppi K, Weintraub D, Coelho M, Perez-Lloret S, Fox SH, Katzenschlager R, Hametner EM, Poewe W, Rascol O, Goetz CG, Sampaio C. The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease. Mov Disord. 2011 Oct;26 Suppl 3(0 3):S42-80. doi: 10.1002/mds.23884.
PubMed 22021174Leung IH, Walton CC, Hallock H, Lewis SJ, Valenzuela M, Lampit A. Cognitive training in Parkinson disease: A systematic review and meta-analysis. Neurology. 2015 Nov 24;85(21):1843-51. doi: 10.1212/WNL.0000000000002145. Epub 2015 Oct 30.
PubMed 26519540Glizer D, MacDonald PA. Cognitive Training in Parkinson's Disease: A Review of Studies from 2000 to 2014. Parkinsons Dis. 2016;2016:9291713. doi: 10.1155/2016/9291713. Epub 2016 Sep 5.
PubMed 27688923Klingberg T. Training and plasticity of working memory. Trends Cogn Sci. 2010 Jul;14(7):317-24. doi: 10.1016/j.tics.2010.05.002. Epub 2010 Jun 16.
PubMed 20630350Morrison AB, Chein JM. Does working memory training work? The promise and challenges of enhancing cognition by training working memory. Psychon Bull Rev. 2011 Feb;18(1):46-60. doi: 10.3758/s13423-010-0034-0.
PubMed 21327348Shipstead Z, Redick TS, Engle RW. Is working memory training effective? Psychol Bull. 2012 Jul;138(4):628-654. doi: 10.1037/a0027473. Epub 2012 Mar 12.
PubMed 22409508Unsworth N, Engle RW. Simple and complex memory spans and their relation to fluid abilities: Evidence from list-length effects. Journal of Memory and Language 54(1): 68-80, 2006.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home-based Working Memory Updating Training on Cognition and Health in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03680170
- Acronym / sponsor ID
- iPARK / dnr 2014-1654
- Conditions
- Parkinson Disease, Cognitive Impairment
- Keywords
- Cognitive rehabilitation, Working memory, Randomized controlled trial, Placebo control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Karlstad University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 21 Sep 2018 (actual)
- 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.
The aim of the iPARK-study is to investigate the effects of a process-based cognitive training program with focus on working memory in patients with Parkinson's Disease (PD). The study is a double blinded, randomized controlled trial with a parallel group design that aim to recruit 80 persons with PD. All patients will undergo 30 sessions (6-7 weeks) of web-based cognitive training performed at home. The working memory training is a process-based training program focusing specific on updating. The placebo program is a low dose short term memory paradigm without updating. A battery of neuropsychological tests (working memory, attention, episodic memory, inhibition control, risk taking and motoric speed) and questionnaires (everyday functioning and psychological health) will be performed before training and directly after training and after 16 weeks. Patient expectation and measures of adherence (motivation and results during training) will be controlled for.
The iPARK trial is expected to provide novel and clinical useful information whether updating training is an effective training paradigm in PD. Further it will hopefully contribute to a better understanding of cognitive function in PD.
Detailed description
Parkinson's Disease (PD) is after Alzheimers disease (AD) the most common neurodegenerative disease with a prevalence of 1% of the population over 60 years of age. The cardinal symptoms are motoric and are believed to be caused by depletion of dopamine in the brain with severe depletion in the striatum. In addition to the motor impairments, there are several non-motor functions also affected, where cognitive decline and dementia are among the most common problems. Some claim that up to 75% of the total PD population will eventually develop dementia. Prior to dementia, milder cognitive problems are common and already at the time of diagnosis up to 42.5% of patients with PD are affected by decline in different cognitive functions. Early cognitive deficits seen is inhibition, shifting, working memory and planning, but a cognitive profile of visuospatial decline, semantic fluency and episodic memory has been connected to Parkinson's Disease Dementia (PDD). The occurrence of Lewy-bodies and Alzheimer type brain pathology is common in PDD but dopamine depletion has also been connected to cognitive decline in healthy elderly and in PD.
Although prescription of dementia medication in PD most likely has increased during the last decade there are limited evidence of treatment effects . This particular patient group is already burdened by polypharmacy and therefore investigating non-pharmacological interventions is of crucial importance. A recent systematic review of cognitive intervention studies in PD suggests that there is evidence of clinically meaningful improvements in overall cognition and moderate to large effect sizes on measures of working memory, processing speed and executive functions. Another review on the topic suggested that the results are promising, at least in the immediate or short term for some cognitive domains, but due to inconsistencies between studies and lack of methodological salience there are still a lot of questions unanswered. Baseline factors such as cognitive functioning, Hoehn and Yahr stage, premorbid intelligence all can have contributing effects on individual differences in training gain. Therefore it is important to thoroughly investigate baseline characteristics.
In the future, studies need to include more participants, be hypothesis driven and include more detail of the cognitive profile, training intervention and outcome measures.
One approach to cognitive training that has received a lot of attention and critique is process-based cognitive training, such as training focusing on working memory (WM) and executive functions (EF). The purpose of the process based approach is to strengthen general cognitive processes important to global cognitive functioning. WM and EF play central roles in several different functions such as episodic memory, reading comprehension and problem solving to mention a few. Research has also shown that WM and EF is negatively affected both in normal and pathological aging, such as PD.
Training of executive functioning and working memory have gained some promising results in healthy adults, showing improvements in working memory and executive functioning but there is also an indication of broader generalizations of training gain. Previously the effect of process-based updating training in healthy young and older individuals has been studied. Results showed that a period of updating training increased Blood Oxygen Level Dependent (BOLD) activity in striatum related to increased cognitive performance in both groups. Also a corresponding effect of training on dopaminergic neurotransmission was detected.
In the light of the dopamine dysfunction in PD, with negative effects on both motoric and cognitive function it is of interest to study if a non-invasive, non-pharmacological intervention can lead to better updating function with increased dopamine levels in patients with PD. The iPARK study is a double blinded randomized controlled trial that will examine the effect of a web-based cognitive training program with focus on updating training.
The primary question asked will be if updating training will improve the ability to update contents in working memory and also if there will be improvements in other cognitive functions such as psychomotor speed, working memory, executive functions and episodic memory. Further the aim is to investigate if there will be improvements in self-perceived everyday cognitive function and psychological health as well as if the effects seen will be sustained over a period of four months. Baseline factors will be investigated to see if they have a modulating effect on training. Further the iPARK trial will determine if a web-based training performed at home without active supervision is a feasible approach in this particular patient group. Compliance, adherence and expectations will be measured systematically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel assigned intervention groups with randomized allocation.The intervention of focus is a web-based working memory updating training. The placebo condition consists of a web-based low dose short term memory training. Both groups received pretesting (pre-test) before 30 sessions (6-8 weeks) of training followed by immediate post-testing (post-test 1) and a long term follow up four months after training (post-test 2)
| Arm | Type | Receives |
|---|---|---|
| Working memory updating training | Experimental | Behavioral: Working memory updating trainingTraining with web-based program on the internet for 30 sessions (4-5 times a week). The result of the training is registered. Intervention Device: web-based cognitive training |
| Placebo training | Placebo comparator | Behavioral: Placebo trainingLow dose, short term memory training. Intervention: Training with computer based program on the internet for 30 sessions (4-5 times a week). Intervention Device: Web-based cognitive training |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Parkinson's Disease according to United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria
- Hoehn and Yahr stage I-III
- Pathological dat scan
- A score of 24 or over on the MMSE AND be without Dementia
- Stable medication over the past three months
Key exclusion criteria (4 listed)
- Unstable medication
- Ongoing cognitive training
- Diagnosis of PDD
- Drug or alcohol abuse
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 |
|---|---|---|
| Working memory updating trainingAlso: Web-based, Computer-based training, Internet-based trainingEach training session includes four working memory updating tasks that is performed at the participants home on their computer via internet. Each training session takes about 20 minutes to perform. | Behavioural | Working memory updating training |
| Placebo trainingAlso: Web-based training, Computer-based training, Internet-based trainingEach training session includes four short term memory tasks that is performed at the participants home on their computer via internet. Each training session takes about 20 minutes to perform. | Behavioural | Placebo training |
Primary outcome
Criterion task
Time frame: 6-8 weeks (pretest-posttest 1)
Improvement on Letter memory after 30 sessions of working memory training. total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance
Criterion task
Time frame: 16 weeks (posttest 1-posttest 2)
Maintenance of Letter memory performance four months after completed working memory training. total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance
30 secondary outcomes
Transfer task n-back
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task n-back
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task digit memory running span
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task digit memory running span
Time frame: 16 weeks (posttest 1-posttest 2)
Updating total score
Time frame: 6-8 weeks (pretest-posttest 1)
Updating total score
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task episodic memory
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task episodic memory
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task digit span
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task digit span
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task visuospatial-span
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task visuospatial-span
Time frame: 16 weeks (posttest 1-posttest 2)
working memory total score
Time frame: 6-8 weeks (pretest-posttest 1)
working memory total score
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task Matrices (WAIS IV)
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task Matrices (WAIS IV)
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task Digit symbol
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task Digit symbol
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task Perdue pegboard
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task Perdue pegboard
Time frame: 16 weeks (posttest 1-posttest 2)
Mental and psychomotor speed total score
Time frame: 6-8 weeks (pretest-posttest 1)
Mental and psychomotor speed total score
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task Stroop test
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task Stroop test
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task Trail Making Test
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task Trail Making Test
Time frame: 16 weeks (posttest 1-posttest 2)
Executive function total score
Time frame: 6-8 weeks (pretest-posttest 1)
Executive function total score
Time frame: 16 weeks (posttest 1-posttest 2)
Transfer task subjective cognitive complaints
Time frame: 6-8 weeks (pretest-posttest 1)
Transfer task subjective cognitive complaints
Time frame: 16 weeks (posttest 1-posttest 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Background: PubMed 16713924de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
- Background: PubMed 19733364Aarsland D, Kurz MW. The epidemiology of dementia associated with Parkinson disease. J Neurol Sci. 2010 Feb 15;289(1-2):18-22. doi: 10.1016/j.jns.2009.08.034. Epub 2009 Sep 4.
- Background: PubMed 19538208Elgh E, Domellof M, Linder J, Edstrom M, Stenlund H, Forsgren L. Cognitive function in early Parkinson's disease: a population-based study. Eur J Neurol. 2009 Dec;16(12):1278-84. doi: 10.1111/j.1468-1331.2009.02707.x. Epub 2009 Jun 15.
- Background: PubMed 24363137Yarnall AJ, Breen DP, Duncan GW, Khoo TK, Coleman SY, Firbank MJ, Nombela C, Winder-Rhodes S, Evans JR, Rowe JB, Mollenhauer B, Kruse N, Hudson G, Chinnery PF, O'Brien JT, Robbins TW, Wesnes K, Brooks DJ, Barker RA, Burn DJ; ICICLE-PD Study Group. Characterizing mild cognitive impairment in incident Parkinson disease: the ICICLE-PD study. Neurology. 2014 Jan 28;82(4):308-16. doi: 10.1212/WNL.0000000000000066. Epub 2013 Dec 20.
- Background: PubMed 20880750Kehagia AA, Barker RA, Robbins TW. Neuropsychological and clinical heterogeneity of cognitive impairment and dementia in patients with Parkinson's disease. Lancet Neurol. 2010 Dec;9(12):1200-1213. doi: 10.1016/S1474-4422(10)70212-X. Epub 2010 Sep 27.
- Background: PubMed 18550595Landau SM, Lal R, O'Neil JP, Baker S, Jagust WJ. Striatal dopamine and working memory. Cereb Cortex. 2009 Feb;19(2):445-54. doi: 10.1093/cercor/bhn095. Epub 2008 Jun 11.
- Background: PubMed 22742929Ekman U, Eriksson J, Forsgren L, Mo SJ, Riklund K, Nyberg L. Functional brain activity and presynaptic dopamine uptake in patients with Parkinson's disease and mild cognitive impairment: a cross-sectional study. Lancet Neurol. 2012 Aug;11(8):679-87. doi: 10.1016/S1474-4422(12)70138-2. Epub 2012 Jun 27.
- Background: PubMed 12023324Ito K, Nagano-Saito A, Kato T, Arahata Y, Nakamura A, Kawasumi Y, Hatano K, Abe Y, Yamada T, Kachi T, Brooks DJ. Striatal and extrastriatal dysfunction in Parkinson's disease with dementia: a 6-[18F]fluoro-L-dopa PET study. Brain. 2002 Jun;125(Pt 6):1358-65. doi: 10.1093/brain/awf134.
- Background: PubMed 22021174Seppi K, Weintraub D, Coelho M, Perez-Lloret S, Fox SH, Katzenschlager R, Hametner EM, Poewe W, Rascol O, Goetz CG, Sampaio C. The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease. Mov Disord. 2011 Oct;26 Suppl 3(0 3):S42-80. doi: 10.1002/mds.23884.
- Background: PubMed 26519540Leung IH, Walton CC, Hallock H, Lewis SJ, Valenzuela M, Lampit A. Cognitive training in Parkinson disease: A systematic review and meta-analysis. Neurology. 2015 Nov 24;85(21):1843-51. doi: 10.1212/WNL.0000000000002145. Epub 2015 Oct 30.
- Background: PubMed 27688923Glizer D, MacDonald PA. Cognitive Training in Parkinson's Disease: A Review of Studies from 2000 to 2014. Parkinsons Dis. 2016;2016:9291713. doi: 10.1155/2016/9291713. Epub 2016 Sep 5.
- Background: PubMed 20630350Klingberg T. Training and plasticity of working memory. Trends Cogn Sci. 2010 Jul;14(7):317-24. doi: 10.1016/j.tics.2010.05.002. Epub 2010 Jun 16.
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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.
Anna S Neely, Prof principal investigator
Karlstad 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 Working memory updating training in people with Parkinson Disease and Cognitive Impairment, run by Umeå University at 1 site in Sweden.
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 6 inclusion and 4 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 22 Jun 2021. 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 Sweden. 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?
Contact Anna S Neely, prof (+46547001545, anna.neely@kau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Criterion task (time frame: 6-8 weeks (pretest-posttest 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03680170, which also lists 26 linked publications.
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 22 Jun 2021.