Mental CompetenceNCT01393353
Cognitive Training in Parkinson's Disease
A study testing Cognitive Training and computer game in people with Mental Competence, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who have a mild cognitive impairment or mild dementia. The control group is "trained" using Nintendo Wii. The main outcome parameter is a neuropsychological evaluation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Competence
- What is being tested?
- Cognitive Training and computer game
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Apr 2014
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parkinson's disease and mild cognitive impairment (MCI) or mild dementia
Who cannot join
- Moderate or severe dementia, other pathologies of the brain, physical conditions that prevent the participation, unsufficient knowledge of german, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Computerized, Multidimensional and Disease Specific Training of Cognition in Patients With M. Parkinson
The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who have a mild cognitive impairment or mild dementia. The control group is "trained" using Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.
- Conditions
- Mental Competence
- Being tested
- Cognitive Training, computer game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingOther
computer gameOther
| Study group | Role | What they receive |
|---|---|---|
| Computer game | Sham comparator | Nintendo Wii Receives: Other: computer game |
| Cognitive Training with Cogniplus | Experimental | CogniPlus Receives: Other: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological parameters: Tests of episodic memory, working memory, executive functions, visio-construction
Neuropsychological tests: mini mental status (MMS), Clock drawing test, Boston Naming Test, Calculating, Semantic Fluency, Phonematic Fluency, California Verbal Learning Test, Corsi Block Tapping Test, Trail Making Test, Digit Span, Testbatterie zur Aufmerksamkeitsprüfung (alteredness, Working Memory, Divided Attention, Flexibility), Wisconsin Card Sorting Test, Apraxias, 5 Points Test, Mosaik Test
Measured: Neuropsychological assessment immediatly before and after the training and 6 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental CompetenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Fuhr, Prof., Principal investigator, University Hospital Basel, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393353
- Sponsor's protocol ID
- UHBS
- Status last verified
- Dec 2014
- First submitted
- 6 Jul 2011
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computerized, Multidimensional and Disease Specific Training of Cognition in Patients With M. Parkinson
- ClinicalTrials.gov ID
- NCT01393353
- Acronym / sponsor ID
- UHBS
- Conditions
- Mental Competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Jul 2011 (estimated)
- 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 study evaluates a computerized cognitive therapy in patients with Parkinson's disease who have a mild cognitive impairment or mild dementia. The control group is "trained" using Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer game | Sham comparator | Other: computer gameNintendo Wii |
| Cognitive Training with Cogniplus | Experimental | Other: Cognitive TrainingCogniPlus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's disease and mild cognitive impairment (MCI) or mild dementia
Key exclusion criteria (1 listed)
- Moderate or severe dementia, other pathologies of the brain, physical conditions that prevent the participation, unsufficient knowledge of german, pregnancy
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 |
|---|---|---|
| Cognitive Training | Other | Cognitive Training with Cogniplus |
| computer game | Other | Computer game |
Primary outcome
Neuropsychological parameters: Tests of episodic memory, working memory, executive functions, visio-construction
Time frame: Neuropsychological assessment immediatly before and after the training and 6 month later
Neuropsychological tests: mini mental status (MMS), Clock drawing test, Boston Naming Test, Calculating, Semantic Fluency, Phonematic Fluency, California Verbal Learning Test, Corsi Block Tapping Test, Trail Making Test, Digit Span, Testbatterie zur Aufmerksamkeitsprüfung (alteredness, Working Memory, Divided Attention, Flexibility), Wisconsin Card Sorting Test, Apraxias, 5 Points Test, Mosaik Test
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 15 Dec 2014.
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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.
Peter Fuhr, Prof. principal investigator
University Hospital Basel, Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training and computer game in people with Mental Competence, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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 15 Dec 2014. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Neuropsychological parameters: Tests of episodic memory, working memory, executive functions, visio-construction (time frame: Neuropsychological assessment immediatly before and after the training and 6 month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2014.