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van CCT (UK)

van CCT (UK)

Effect of Health games on Cognitive Function in Parkinsonís Disease

- candidate number23579
- NTR NumberNTR5637
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2016
- Secondary IDs141128 MEC/IRB Maastricht
- Public TitleEffect of Health games on Cognitive Function in Parkinsonís Disease
- Scientific TitleThe Parkin'play study: a phase II randomized controlled trial to assess the effects of a health game on cognition in Parkinson's disease
- hypothesisTo 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) studiedMild Cognitive Impairment
- Inclusion criteriaDiagnosis 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 criteriaHoehn & 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate30-jun-2018
- Target number of participants222
- InterventionsThe 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 outcomecognition as measured by a standard neuropsychological assessment and online assessment
- Secondary outcomeCompliance 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.
- Timepointsbaseline: 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
- statusplanned
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- Publications
- Brief summaryCognitive 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)
- RECORD7-jan-2016 - 28-feb-2016

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