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CompletedNCT03285347Updated Jan 26, 2021

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

An interventional study of Computer-based cognitive training in Parkinson Disease and Executive Dysfunction, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2021-01-26.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Executive Dysfunction

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Keywords

  • parkinson
  • executive dysfunction
  • attention
  • computer-based cognitive training
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

  • 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.

Interventions

  • DeviceComputer-based cognitive training

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

05

What researchers measure

Primary outcomes

  1. SDMT

    Symbol digit modalities test, neuropsychological test of processing speed

    Time frame: 2 minutes

  2. PDQ-39

    Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease

    Time frame: 20 minutes

Secondary outcomes

  1. HADS

    Hospital anxiety and depression screening

    Time frame: 10 minutes

  2. Digit span

    Digit span Wais-IV; Working memory

    Time frame: 10 minutes

  3. Verbal fluency

    S-Words, animal-names and A/F-words

    Time frame: 3 minutes

  4. Stroop colour/word test

    Stroop colour/Word test, respone inhibition

    Time frame: 3 minutes

  5. Trail Making A and B

    Trail Making A and B, cognitive flexibility

    Time frame: 5 minutes

06

Study locations

1 site
  • Bispebjerg Hospital
    Copenhagen, Region Hovedstaden 2400, Denmark
07

References and documents

Publications

  • Svaerke K, Faerk AK, Riis A, Stiegnitz von Ehrenfels SEM, Mogensen J, Lokkegaard A. Effects of Computer-Based Cognitive Rehabilitation on Attention, Executive Functions, and Quality of Life in Patients with Parkinson's Disease: A Randomized, Controlled, Single-Blinded Pilot Study. Dement Geriatr Cogn Disord. 2021;50(6):519-528. doi: 10.1159/000520591. Epub 2022 Jan 5. PubMed 34986487 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03285347
Lead sponsor
Bispebjerg Hospital
Responsible party
Katrine Sværke (Stud. Psych., Bispebjerg Hospital) — Principal investigator
First posted
Sep 18, 2017
Start date
Oct 1, 2017
Primary completion
Feb 29, 2020
Completion
Jun 30, 2020
Last update
Jan 26, 2021

Study contacts

Annemette Løkkegaard, Ph.d.
study director · Doctor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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