Parkinson DiseaseNCT03285347
Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
A study testing Computer-based cognitive training in people with Parkinson Disease and Executive Dysfunction, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Executive Dysfunction
- What is being tested?
- Computer-based cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- People without Parkinson's disease
- Parkinson's patients not included in the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Parkinson Disease, Executive Dysfunction
- Being tested
- Computer-based cognitive training
- Keywords
- parkinson, executive dysfunction, attention, computer-based cognitive training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based cognitive trainingDevice
Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.
| Study group | Role | What they receive |
|---|---|---|
| Brain+ Evolution | Experimental | Intervention: Training with computer-based programme Brain+ Evolution for 8 weeks, receiving follow-ups every second week.
Computer-based cognitive training. Receives: Device: Computer-based cognitive training |
| Scientific Brain Training PRO | Experimental | Intervention: Training with computer-based programme Scientific Brain Training PRO for 8 weeks, receiving follow-ups every second week.
Computer-based cognitive training. Receives: Device: Computer-based cognitive training |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
SDMT
Symbol digit modalities test, neuropsychological test of processing speed
Measured: 2 minutes
PDQ-39
Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease
Measured: 20 minutes
Secondary outcomes (5)
HADS
Hospital anxiety and depression screening
Measured: 10 minutes
Digit span
Digit span Wais-IV; Working memory
Measured: 10 minutes
Verbal fluency
S-Words, animal-names and A/F-words
Measured: 3 minutes
Stroop colour/word test
Stroop colour/Word test, respone inhibition
Measured: 3 minutes
Trail Making A and B
Trail Making A and B, cognitive flexibility
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Oct 2017
- Primary completion29 Feb 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Sværke, Bispebjerg Hospital
- Investigators
- Annemette Løkkegaard, Ph.d., Study director, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285347
- Sponsor's protocol ID
- H-17000220
- Status last verified
- Jan 2021
- First submitted
- 14 Sep 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03285347
- Acronym / sponsor ID
- H-17000220
- Conditions
- Parkinson Disease, Executive Dysfunction
- Keywords
- parkinson, executive dysfunction, attention, computer-based cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brain+ Evolution | Experimental | Device: Computer-based cognitive trainingIntervention: Training with computer-based programme Brain+ Evolution for 8 weeks, receiving follow-ups every second week. Computer-based cognitive training. |
| Scientific Brain Training PRO | Experimental | Device: Computer-based cognitive trainingIntervention: Training with computer-based programme Scientific Brain Training PRO for 8 weeks, receiving follow-ups every second week. Computer-based cognitive training. |
| Control group | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- People without Parkinson's disease
- Parkinson's patients not included in the above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based cognitive trainingComputer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains. | Device | Brain+ Evolution, Scientific Brain Training PRO |
Primary outcome
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
5 secondary outcomes
HADS
Time frame: 10 minutes
Digit span
Time frame: 10 minutes
Verbal fluency
Time frame: 3 minutes
Stroop colour/word test
Time frame: 3 minutes
Trail Making A and B
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 34986487Svaerke 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemette Løkkegaard, Ph.d. study director
Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based cognitive training in people with Parkinson Disease and Executive Dysfunction, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDMT (time frame: 2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.