Cognitive Training in Parkinson's Disease, the iPARK Study

NCT03680170 | Unknown

• 2 other identifiers: dnr 2014-1654dnr 2017-02371
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease; Cognitive Impairment

Keywords

Cognitive rehabilitation; Working memory; Randomized controlled trial; Placebo control

Outcome Measures

Primary Outcomes (2)

• 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

  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

  16 weeks (posttest 1-posttest 2)

Secondary Outcomes (30)

• Transfer task n-back

  6-8 weeks (pretest-posttest 1)

• Transfer task n-back

  16 weeks (posttest 1-posttest 2)

• Transfer task digit memory running span

  6-8 weeks (pretest-posttest 1)

• Transfer task digit memory running span

  16 weeks (posttest 1-posttest 2)

• Updating total score

  6-8 weeks (pretest-posttest 1)

Other Outcomes (20)

• Hospital Anxiety Depression scale (Depression and anxiety)

  6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2)

• Short Form Health Survey sf-36 (Health status)

  6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2)

• Short version of the Karolinska Sleep Questionnaire (Sleep status)

  6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2)

Study Arms (2)

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

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

Behavioral: Placebo training

Interventions

Working memory updating training BEHAVIORAL

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.

Also known as: Web-based, Computer-based training, Internet-based training

Working memory updating training

Placebo training BEHAVIORAL

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.

Also known as: Web-based training, Computer-based training, Internet-based training

Placebo training

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unstable medication
• Ongoing cognitive training
• Diagnosis of PDD
• Drug or alcohol abuse

Sponsors & Collaborators

• Umeå University: lead
• Karlstad University: collaborator

Study Sites (1)

Umeå University department of psychology

Umeå, Västerbotten County, 90187, Sweden

RECRUITING

Related Publications (24)

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  PMID: 19733364 BACKGROUND

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• Yarnall 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.

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• Kehagia 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.

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• Ekman 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.

  PMID: 22742929 BACKGROUND

• Ito 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.

  PMID: 12023324 BACKGROUND

• Seppi 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.

  PMID: 22021174 BACKGROUND

• Leung 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.

  PMID: 26519540 BACKGROUND

• Glizer 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.

  PMID: 27688923 BACKGROUND

• Klingberg 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.

  PMID: 20630350 BACKGROUND

• Morrison 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.

  PMID: 21327348 BACKGROUND

• Shipstead 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.

  PMID: 22409508 BACKGROUND

• Unsworth 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.

  BACKGROUND

• Unsworth N, Engle RW. The nature of individual differences in working memory capacity: active maintenance in primary memory and controlled search from secondary memory. Psychol Rev. 2007 Jan;114(1):104-32. doi: 10.1037/0033-295X.114.1.104.

  PMID: 17227183 BACKGROUND

• Gabrieli JDE, Singh J, Stebbins GT, & Goetz CG. Reduced working memory span in Parkinson's disease: Evidence for the role of frontostriatal system in working and strategic memory. Neuropsychology, 10(3): 322-332,1996.

  BACKGROUND

• McCabe DP, Roediger HL, McDaniel MA, Balota DA, Hambrick DZ. The relationship between working memory capacity and executive functioning: evidence for a common executive attention construct. Neuropsychology. 2010 Mar;24(2):222-243. doi: 10.1037/a0017619.

  PMID: 20230116 BACKGROUND

• Chein JM, Morrison AB. Expanding the mind's workspace: training and transfer effects with a complex working memory span task. Psychon Bull Rev. 2010 Apr;17(2):193-9. doi: 10.3758/PBR.17.2.193.

  PMID: 20382919 BACKGROUND

• Dahlin E, Neely AS, Larsson A, Backman L, Nyberg L. Transfer of learning after updating training mediated by the striatum. Science. 2008 Jun 13;320(5882):1510-2. doi: 10.1126/science.1155466.

  PMID: 18556560 BACKGROUND

• Backman L, Nyberg L, Soveri A, Johansson J, Andersson M, Dahlin E, Neely AS, Virta J, Laine M, Rinne JO. Effects of working-memory training on striatal dopamine release. Science. 2011 Aug 5;333(6043):718. doi: 10.1126/science.1204978.

  PMID: 21817043 BACKGROUND

• Dahlin E, Nyberg L, Backman L, Neely AS. Plasticity of executive functioning in young and older adults: immediate training gains, transfer, and long-term maintenance. Psychol Aging. 2008 Dec;23(4):720-30. doi: 10.1037/a0014296.

  PMID: 19140643 BACKGROUND

• Backman L, Waris O, Johansson J, Andersson M, Rinne JO, Alakurtti K, Soveri A, Laine M, Nyberg L. Increased dopamine release after working-memory updating training: Neurochemical correlates of transfer. Sci Rep. 2017 Aug 2;7(1):7160. doi: 10.1038/s41598-017-07577-y.

  PMID: 28769095 BACKGROUND

• Domellof ME, Walton L, Boraxbekk CJ, Backstrom D, Josefsson M, Forsgren L, Stigsdotter Neely A. Evaluating a frontostriatal working-memory updating-training paradigm in Parkinson's disease: the iPARK trial, a double-blinded randomized controlled trial. BMC Neurol. 2020 Sep 7;20(1):337. doi: 10.1186/s12883-020-01893-z.

  PMID: 32894075 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anna S Neely, Prof

  Karlstad University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Neely, prof

CONTACT

+46547001545; anna.neely@kau.se

Magdalena E Domellöf, Phd

CONTACT

+4690786 70 22; magdalena.domellof@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: At the pre and first post test the person performing the testing is blinded to which group the participant is allocated to. The participant is blinded to which intervention he/she is participating in. At the second post-test the research assistant know which training the participant has been allocated to. Person performing the statistical analysis will be blinded to study group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: September 21, 2018
• Study Start: February 1, 2017
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

SE (1)