neurologische aandoening change in cognition
Conditions
Interventions
The subjects receive treatment as usual and an account for health game
AquaSnap, which they can play at home on a computer of an iPad. In AquaSnap,
five domains of cognitive functioning are trained:
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Hoehn & Yahr stage 4 or 5 - Advanced problems in cognitive functioning: Montreal Cognitive Assessment (MoCa) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the "overall cognition compound score" from the standard neuropsychological battery that is based on the following cognitive domains: executive function/attention, memory, language and visual perception/construction at 12 and 24 weeks of follow-up. A compound score for overall (global) cognitive function will be calculated as the mean score of all test Z-scores (domains). The change from baseline to the follow-up assessments will also be analyzed on a domain level by summing the standardized scores of the separate tests per domain. A second primary outcome is the MyCQ score, which is an integral part of the AquaSnap game. Performances on the (monthly taken) MyCQ assessment are translated into a change in difficulty of AquaSnap. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are mood, subjective cognition (complaints), functional cognitive status, quality of life, NART, MDS-UPDRS III,HADS, CFQ, PDCFR, PDQ39, BIS, motor function, and AquaSnap evaluation. The addition of the 24 week follow up assessment (as secondary endpoint) provides us information about the course of the effect and whether it persists in either those who continue and stop playing the game and the attractiveness of the game. fMRI outcome: At two moments (baseline and week 12) 40 subjects will receive an MRI scan. The main study parameters of the fMRI sub-study are change in the activity of the resting-state network associated with executive function that covers several medial-frontal areas, including the anterior cingulate, paracingulate and occipital cortex. The fMRI sub-study will help to interpret the concurrent clinical improvements, and may serve as a surrogate outcome to detect subclinical improvements as proof-of-concept for the efficacy of the intervention, even in the face of a potential negative clinical outcome. | — |
Countries
Netherlands
Outcome results
None listed