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Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03285347
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Katrine Sværke, Bispebjerg Hospital

Brief Summary:
The current study adresses the effect of two different computer-based cognitive trianing programmes on attention and executive functions in patients with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Executive Dysfunction Device: Computer-based cognitive training Not Applicable

Detailed Description:
The current study adresses the effect of two different computer-based cognitive training programmes (Brain+ Evolution and Scientific Brain Training PRO) on attention and executive functions in patients with Parkinson's disease. The patients are assigned to one of three groups. Two training groups with each their programme, and a control Group. The training groups will train at home for 8 weeks with follow-ups every second week. The control group will not train at home, but will also receive a follow-up with computer-based stimuli (computerized Card game) every second week, to minimize the possibility that a possible effect is due to the follow-up's with a professional, and not due to the computer training at home.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two intervention Groups training with each their computer-based cognitive programme, one control Group receiving no intervention except for the same amount of follow-ups as the two intervention Groups.
Masking: Single (Outcomes Assessor)
Masking Description: Before and after the intervention period, the patients are tested in a neuropsychological battery to asses their executive functioning. The tester is blinded to the Group allocation of the patients.
Primary Purpose: Health Services Research
Official Title: The Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brain+ Evolution

Intervention: Training with computer-based programme Brain+ Evolution for 8 weeks, receiving follow-ups every second week.

Computer-based cognitive training.

Device: Computer-based cognitive training
Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.

Experimental: Scientific Brain Training PRO

Intervention: Training with computer-based programme Scientific Brain Training PRO for 8 weeks, receiving follow-ups every second week.

Computer-based cognitive training.

Device: Computer-based cognitive training
Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.

No Intervention: Control group
This Group receives no intervention except for the same amount of follow-ups as the two training Groups. This is done to ensure that an effect of training is not aqtually due to the follow-up's with a professional.



Primary Outcome Measures :
  1. SDMT [ Time Frame: 2 minutes ]
    Symbol digit modalities test, neuropsychological test of processing speed

  2. PDQ-39 [ Time Frame: 20 minutes ]
    Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease


Secondary Outcome Measures :
  1. HADS [ Time Frame: 10 minutes ]
    Hospital anxiety and depression screening

  2. Digit span [ Time Frame: 10 minutes ]
    Digit span Wais-IV; Working memory

  3. Verbal fluency [ Time Frame: 3 minutes ]
    S-Words, animal-names and A/F-words

  4. Stroop colour/word test [ Time Frame: 3 minutes ]
    Stroop colour/Word test, respone inhibition

  5. Trail Making A and B [ Time Frame: 5 minutes ]
    Trail Making A and B, cognitive flexibility



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Parkinson's disease AND
  • Montreal cognitive assesment (MOCA)-score between 22-28
  • Motorically cabable of using an iPad
  • Not receiving antipsychotic medicine
  • No comorbid diseases which might influence the level of executive functioning, for an example ADHD or acquired brain damage

Exclusion Criteria:

  • People without Parkinson's disease
  • Parkinson's patients not included in the above inclusion criteria

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): NCT03285347


Contacts
Contact: Katrine Sværke, Student 004521251087 katrine.wordenskjold.svaerke@regionh.dk
Contact: Annemette Løkkegaard, Ph.d. annemette.loekkegaard@regionh.dk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Region Hovedstaden, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Study Director: Annemette Løkkegaard, Ph.d. Doctor

Responsible Party: Katrine Sværke, Stud. Psych., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03285347     History of Changes
Other Study ID Numbers: H-17000220
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katrine Sværke, Bispebjerg Hospital:
parkinson
executive dysfunction
attention
computer-based cognitive training

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases