|- candidate number||23579|
|- NTR Number||NTR5637|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jan-2016|
|- Secondary IDs||141128 MEC/IRB Maastricht|
|- Public Title||Effect of Health games on Cognitive Function in Parkinsonís Disease|
|- Scientific Title||The Parkin'play study: a phase II randomized controlled trial to assess the effects of a health game on cognition in Parkinson's disease|
|- hypothesis||To evaluate the effects of a versatile web-based health game on cognition and compliance in Parkinsonís disease with mild cognitive impairment.|
|- Healt Condition(s) or Problem(s) studied||Mild Cognitive Impairment|
|- 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,
Stable dopaminergic medication within last 3 months.
|- Exclusion criteria||Hoehn & Yahr stage 4 or 5,|
Advanced problems in cognitive functioning: Montreal Cognitive Assessment (MoCa) < 21/30,
≠ Habitual gamers (>1hr games/week in preceding year),
≠ Active depression or psychosis and/or treatment with anti≠depressant or anti≠psychotic drugs,
≠ 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,
≠ Excessive daytime sleepiness (Epworth Sleepiness Scale score >10),
≠ (MRI substudy exclusion: any piece of metal in the body, and/or claustrophobia).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2016|
|- planned closingdate||30-jun-2018|
|- Target number of participants||222|
|- Interventions||The intervention group receives a computerized cognitive training (health game) for a first period of 12 weeks. During this first period, the control group is placed on a waiting list. At the start of the second period of 12 weeks, both the intervention and the control group are allowed to receive the cognitive training.|
|- Primary outcome||cognition as measured by a standard neuropsychological assessment and online assessment|
|- Secondary outcome||Compliance will be registered during the trial. This includes duration of playtime and whether or not subjects continue playing the game after 12 weeks.|
MDS-UPDRS is used to score motor functions: speech, facial expression, tremor at rest, rigidity, hand movements, posture, gait, etc.
Several non-motor symptoms:
- depression (HADS),
- a self-report evaluation of perception, memory and motor-function in daily life (CFQ),
- functional abnormalities associated to cognitive impairment (PD-CFR),
- functional disability (pre-R-ODS),
- quality of life (PDF-39),
- impulsive behavior (BIS-11).
Biological endpoints (fMRI): 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.
|- Timepoints||baseline: t=0|
12 weeks: t=1
24 weeks: t=2
Cognition is measured on all timepoints by calculating a z-score on a standard neuropsychological assessment and several self report questionnaires (HADS, CFQ, PD-CFR, Pre-R-ODS, PDQ39, and BIS-11).
Compliance is measured on all timepoints.
Motor symptoms are measured on all timepoints using the UPDRS-PD part III (motor symptoms).
Biological entpoints are measured on t=0 and t=1 in a subgroup of 40 participants using functional magnetic resonance imaging (fMRI).
|- Trial web site||www.parkinplaystudie.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Kuijf|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Kuijf|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+)|
|- Brief summary||Cognitive impairment is an important non-motor symptom in PD and major determinant of the quality of life. The study aims to evaluate the effects of a versatile web-based health game on cognition and compliance in Parkinsonís disease with mild cognitive impairment. |
|- Main changes (audit trail)|
|- RECORD||7-jan-2016 - 28-feb-2016|