- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03285347
Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
January 25, 2021 updated by: Katrine Sværke, Bispebjerg Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Region Hovedstaden
-
Copenhagen, Region Hovedstaden, Denmark, 2400
- Bispebjerg Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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. |
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SDMT
Time Frame: 2 minutes
|
Symbol digit modalities test, neuropsychological test of processing speed
|
2 minutes
|
|
PDQ-39
Time Frame: 20 minutes
|
Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HADS
Time Frame: 10 minutes
|
Hospital anxiety and depression screening
|
10 minutes
|
|
Digit span
Time Frame: 10 minutes
|
Digit span Wais-IV; Working memory
|
10 minutes
|
|
Verbal fluency
Time Frame: 3 minutes
|
S-Words, animal-names and A/F-words
|
3 minutes
|
|
Stroop colour/word test
Time Frame: 3 minutes
|
Stroop colour/Word test, respone inhibition
|
3 minutes
|
|
Trail Making A and B
Time Frame: 5 minutes
|
Trail Making A and B, cognitive flexibility
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Annemette Løkkegaard, Ph.d., doctor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
February 29, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
September 14, 2017
First Submitted That Met QC Criteria
September 14, 2017
First Posted (Actual)
September 18, 2017
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-17000220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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