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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 : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Katrine Sværke, Bispebjerg Hospital

September 14, 2017
September 18, 2017
June 5, 2018
October 1, 2017
May 30, 2019   (Final data collection date for primary outcome measure)
  • SDMT [ Time Frame: 2 minutes ]
    Symbol digit modalities test, neuropsychological test of processing speed
  • PDQ-39 [ Time Frame: 20 minutes ]
    Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease
Same as current
Complete list of historical versions of study NCT03285347 on ClinicalTrials.gov Archive Site
  • HADS [ Time Frame: 10 minutes ]
    Hospital anxiety and depression screening
  • Digit span [ Time Frame: 10 minutes ]
    Digit span Wais-IV; Working memory
  • Verbal fluency [ Time Frame: 3 minutes ]
    S-Words, animal-names and A/F-words
  • Stroop colour/word test [ Time Frame: 3 minutes ]
    Stroop colour/Word test, respone inhibition
  • Trail Making A and B [ Time Frame: 5 minutes ]
    Trail Making A and B, cognitive flexibility
  • HADS [ Time Frame: 10 minutes ]
    Hospital anxiety and depression screening
  • Digit span [ Time Frame: 10 minutes ]
    Digit span Wais-IV; Working memory
  • Verbal fluency [ Time Frame: 3 minutes ]
    S-Words, animal-names and A/F-words
  • Stroop colour/word test [ Time Frame: 3 minutes ]
    Stroop colour/Word test, respone inhibition
  • Trail Making A and B [ Time Frame: 5 minutes ]
    Train Making A and B, cognitive flexibility
Not Provided
Not Provided
 
Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
The Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
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.
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.
Interventional
Not Applicable
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
  • Parkinson Disease
  • Executive Dysfunction
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: Brain+ Evolution

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

    Computer-based cognitive training.

    Intervention: Device: Computer-based cognitive training
  • 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.

    Intervention: Device: Computer-based cognitive training
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
December 31, 2019
May 30, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact: Katrine Sværke, Student 004521251087 katrine.wordenskjold.svaerke@regionh.dk
Contact: Annemette Løkkegaard, Ph.d. annemette.loekkegaard@regionh.dk
Denmark
 
 
NCT03285347
H-17000220
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Katrine Sværke, Bispebjerg Hospital
Bispebjerg Hospital
Not Provided
Study Director: Annemette Løkkegaard, Ph.d. Doctor
Bispebjerg Hospital
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP