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Cognitive Training in Parkinson's Disease, the iPARK Study (iPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03680170
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Karlstad University
Information provided by (Responsible Party):
Anna Stigsdotter Neely, Umeå University

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Cognitive Impairment Behavioral: Working memory updating training Behavioral: Placebo training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: The Effect of Home-based Working Memory Updating Training on Cognition and Health in Patients With Parkinson's Disease
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Working memory updating training

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
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.
Other Names:
  • Web-based
  • Computer-based training
  • Internet-based training

Placebo Comparator: Placebo training

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
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.
Other Names:
  • Web-based training
  • Computer-based training
  • Internet-based training




Primary Outcome Measures :
  1. 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

  2. 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



Secondary Outcome Measures :
  1. Transfer task n-back [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    Improvement on updating performance measured by n-back (1,2 and 3 back) after 30 sessions of working memory training.

    1. back total score: 0-90 higher score indicate better performance
    2. back total score: 0-90 higher score indicate better performance
    3. 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


  2. Transfer task n-back [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    Maintenance of updating performance measured by n-back (1,2 and 3 back) four months after completed working memory training.

    1. back total score: 0-90 higher score indicate better performance
    2. back total score: 0-90 higher score indicate better performance
    3. 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


  3. Transfer task digit memory running span [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  4. Transfer task digit memory running span [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  5. Updating total score [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  6. Updating total score [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  7. Transfer task episodic memory [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  8. Transfer task episodic memory [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  9. Transfer task digit span [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  10. Transfer task digit span [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  11. Transfer task visuospatial-span [ Time Frame: 6-8 weeks (pretest-posttest 1) ]
    Maintenance of visuospatial working memory performance measured by visuospatial span task, 0-18 higher score indicate better performance

  12. Transfer task visuospatial-span [ Time Frame: 16 weeks (posttest 1-posttest 2) ]
    Maintenance of visuospatial working memory performance measured by visuospatial span task, total score 0-18 higher score indicate better performance

  13. working memory total score [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  14. working memory total score [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  15. Transfer task Matrices (WAIS IV) [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  16. Transfer task Matrices (WAIS IV) [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  17. Transfer task Digit symbol [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  18. Transfer task Digit symbol [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  19. Transfer task Perdue pegboard [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  20. Transfer task Perdue pegboard [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  21. Mental and psychomotor speed total score [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  22. Mental and psychomotor speed total score [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  23. Transfer task Stroop test [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  24. Transfer task Stroop test [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  25. Transfer task Trail Making Test [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  26. Transfer task Trail Making Test [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  27. Executive function total score [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  28. Executive function total score [ Time Frame: 16 weeks (posttest 1-posttest 2) ]

    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


  29. Transfer task subjective cognitive complaints [ Time Frame: 6-8 weeks (pretest-posttest 1) ]

    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


  30. Transfer task subjective cognitive complaints [ Time Frame: 16 weeks (posttest 1-posttest 2) ]
    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


Other Outcome Measures:
  1. Hospital Anxiety Depression scale (Depression and anxiety) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]
    Severity of depression and anxiety symptoms measured by Hospital Anxiety Depression scale Anxiety score: 0-21 higher score indicate more anxiety Depression score: 0-21 higher score indicate more depression

  2. Short Form Health Survey sf-36 (Health status) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]
    Health status measured by the Short Form Health Survey (sf-36) physical functioning score: 0-100 higher scores indicate less problems role limitations score: 0-100 higher scores indicate less problems energy fatigue score: 0-100 higher scores indicate less problems emotional well being score: 0-100 higher scores indicate less problems social functioning score: 0-100 higher scores indicate less problems pain score: 0-100 higher scores indicate less problems general health: 0-100 higher scores indicate less problems

  3. Short version of the Karolinska Sleep Questionnaire (Sleep status) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]
    Sleep status measured by the Short version of the Karolinska Sleep Questionnaire total score: 5-30 higher scores indicate better sleep

  4. Parkinson's Disease Questionnaire PDQ-39 (Function and well being) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]
    Function and well being measured by Parkinson's Disease Questionnaire-39 (PDQ39) Mobility score: 0-100 higher scores indicate more problems Activity of Daily Living score: 0-100 higher scores indicate more problems Emotional well being score: 0-100 higher scores indicate more problems Stigma score: 0-100 higher scores indicate more problems Social support score: 0-100 higher scores indicate more problems Cognition score: 0-100 higher scores indicate more problems Communication score: 0-100 higher scores indicate more problems Bodily discomfort score: 0-100 higher scores indicate more problems Summary index: 0-100 higher scores indicate more problems

  5. Urgency, Premeditation, Perseverance and Sensation Seeking Questionnaire UPPS (Impulsivity and risk taking) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]
    Impulsivity and risk taking measured by Urgency, Premeditation, Perseverance and Sensation Seeking Questionnaire (UPPS) Urgency score: 0-100 higher score indicate more urgency Premeditation score:0-100 higher score indicate less premeditation Perseverance score: 0-100 higher score indicate less perseverance Sensation seeking score: 0-100 higher score indicate more sensation seeking.

  6. Balloon Analogue Risk Taking Task BART (Impulsivity and risk taking) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]

    Impulsivity and risk taking measured by the Balloon Analogue Risk Taking Task (BART).

    Number of explosions: 0-30


  7. Checklist Individual Strength Questionnaire CIS (Fatigue) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]

    Fatigue measured by Checklist Individual Strength Questionnaire (CIS) after 30 sessions of working memory training.

    total score: 20-140


  8. Adherence (Task engagement) [ Time Frame: 6-8 weeks (during training) ]
    Task engagement is measured by self assessed motivation to training and ability to stay focused during training measured before and after each training session.

  9. Compliance (Finishing training within time frame) [ Time Frame: 6-8 weeks (during training) ]
    Compliance is measured by number of participants finishing the training within time frame, 6-8 weeks.

  10. Age [ Time Frame: before training (pretest) ]
    Demographic characteristic: age at baseline

  11. sex [ Time Frame: before training (pretest) ]
    Demographic characteristic: sex

  12. Educational level [ Time Frame: before training (pretest) ]
    Demographic characteristic: educational level

  13. Disease duration [ Time Frame: before training (pretest) ]
    Demographic characteristic: disease duration

  14. Disease stage [ Time Frame: before training (pretest) ]
    Disease characteristic: disease stage (Hoehn and Yahr stage) Range 0-4

  15. Levodopa Equivalent Dose (Medication for Parkinson's Disease) [ Time Frame: 6-8 weeks (pretest- posttest 1) 16 weeks (posttest 1 - posttest 2) ]
    Medication use measured by Levodopa Equivalent Dose

  16. Unified Parkinson's Disease Rating Scale (Motor symptoms) [ Time Frame: before training (pretest) ]
    Motor symptoms assessed by the Unified Parkinson's Disease Rating Scale part 3 Total score:0-108 (higher scores indicate more motor symptoms)

  17. Mini Mental State Examination (Global cognitive function) [ Time Frame: before training (pretest) ]
    Global cognitive function measured by Mini Mental State Examination (MMSE) Total score: 24-30 (patients with lower scores is not included), lower scores indicate worse performance.

  18. Side (left or right) most affected of Parkinson's Disease symptoms [ Time Frame: before training (pretest) ]
    Disease characteristic: Most affected and starting side (Parkinsons symptoms)

  19. Swedish vocabulary test SRB (Verbal ability) [ Time Frame: before training (pretest) ]
    Verbal ability measured by Swedish vocabulary test (SRB). total score: 0-30 higher scores indicate better performance

  20. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) [ Time Frame: 6-8 weeks (during training and at post test) ]
    All adverse events connected to training reported from participants and/or family members throughout the training period and after training are registered.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Parkinson's Disease according to United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria
  2. Hoehn and Yahr stage I-III
  3. Pathological dat scan
  4. A score of 24 or over on the MMSE AND be without Dementia
  5. Stable medication over the past three months
  6. Owns and is able to use a home based computer or tablet with internet connection.

Exclusion Criteria:

  1. Unstable medication
  2. Ongoing cognitive training
  3. Diagnosis of PDD
  4. Drug or alcohol abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680170


Contacts
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Contact: Anna S Neely, prof +46547001545 anna.neely@kau.se
Contact: Magdalena E Domellöf, Phd +4690786 70 22 magdalena.domellof@umu.se

Locations
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Sweden
Umeå University department of psychology Recruiting
Umea, Västerbotten, Sweden, 90187
Contact: Magdalena E Domellöf, Phd    +46907867022    magdalena.domellof@umu.se   
Contact: Anna Stigsdotter Neely, Prof    +46547001545    anna.neely@kau.se   
Sponsors and Collaborators
Umeå University
Karlstad University
Investigators
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Principal Investigator: Anna S Neely, Prof Karlstad University
Publications:
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Stigsdotter Neely, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT03680170    
Other Study ID Numbers: dnr 2014-1654
dnr 2017-02371 ( Other Grant/Funding Number: The Swedish Research Council )
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Stigsdotter Neely, Umeå University:
Cognitive rehabilitation
Working memory
Randomized controlled trial
Placebo control
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases