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

The Parkin'play study: a phase II randomized controlled trial to assess the effects of a health game on cognition in Parkinson's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21375

Enrollment

222

Registered

2016-01-07

Start date

2016-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild cognitive impairment

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

Eligibility

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 cutoff 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

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 antidepressant or antipsychotic drugs, Medication interfering with cognition including anticholinergic medication, benzodiazepines not used as sleep medication and stimulants (i.e. methylphenidate), Premorbid intelligence 10), (MRI substudy exclusion: any piece of metal in the body, and/or claustrophobia).

Design outcomes

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Primary

Measure	Time frame
cognition as measured by a standard neuropsychological assessment and online assessment	—

Contacts

Public ContactM. Kuijf

Oxfordlaan 10

Email. mark.kuijf@mumc.nlPhone. 043 38 77056

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)