Effect of Health games on Cognitive Function in Parkinson*s Disease

Phase 2

Completed

Conditions: neurologische aandoening
change in cognition
parkinson's disease

Registration Number: NL-OMON43614

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 222

Inclusion Criteria

- Diagnosis of idiopathic PD according to the UK Brain Bank Criteria
- Cognitive impairment at baseline in line with the Level 1 criteria for MCI and a cut-off of 1.5 SD below the normative mean.
- Aged between 40 and 75 years old.
- Not receiving any other cognitive therapy or intensified physical activity during the study
- Relatively stable dopaminergic medication (and relatively stable stimulation parameters in case of a neurostimulator) within last three months, or the change in medication does not influence cognition (LED change of less than 50% increase or decrease).
- Must have access to internet.

Exclusion Criteria

- Hoehn & Yahr stage 4 or 5
- Advanced problems in cognitive functioning: Montreal Cognitive Assessment (MoCa) < 19/30
- Habitual gamers (>1hr games/week in preceding year)
- Active depression or psychosis and/or treatment with anti-depressant or anti-psychotic drugs which influences cognition.
- Medication interfering with cognition including anticholinergic medication, benzodiazepines not used as sleep medication and stimulants (i.e. methylphenidate)
- Premorbid intelligence < 86 based on the Dutch National Adult Reading test (NART)
- Severe auditory or visual deficits
- History of active thyroid disease, stroke with residual deficits, severe hypertension or diabetes or head trauma interfering in cognition
- (MRI substudy exclusion: any piece of metal in the body, and/or claustrophobia).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the overall cognition compound score from the<br /><br>standard neuropsychological battery that is based on the following cognitive<br /><br>domains: executive function/attention, memory, language and visual<br /><br>perception/construction at 12 and 24 weeks of follow-up. A compound score for<br /><br>overall (global) cognitive function will be calculated as the mean score of all<br /><br>test Z-scores (domains).<br /><br><br /><br>The change from baseline to the follow-up assessments will also be analyzed on<br /><br>a domain level by summing the standardized scores of the separate tests per<br /><br>domain.<br /><br><br /><br>A second primary outcome is the MyCQ score, which is an integral part of the<br /><br>AquaSnap game. Performances on the (monthly taken) MyCQ assessment are<br /><br>translated into a change in difficulty of AquaSnap. </p><br>

Secondary Outcome Measures