The main aim of this phase-II-proof-of-principle study is to test whether the health game AquaSnap offers improvement of cognitive impairment in PD patients with mild cognitive impairment, using an RCT. The long-term ambition is to test whether the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neurologische aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Parkinson*s disease (PD) is a common neurodegenerative disorder that is
characterized by both motor symptoms (tremor, slowness and poverty of
movements, gait difficulties) and non-motor symptoms (cognitive impairment,
depression, sleep disorders). In the last decades, these non-motor symptoms
have been increasingly recognized as major contributors to the decreased
quality of life in PD patients. Cognitive impairment is already noticeable in
early non-demented stages of PD, and these cognitive deficits worsen with
disease progression. The cumulative prevalence of dementia is as high as 80% in
the advanced stages of PD.
Current treatment strategies are partially effective at best, and even with
best medical management, cognitive impairment remains a common and debilitating
problem for the majority of patients with PD. Therefore, adequate strategies to
better treat cognitive impairment and to possibly decelerate the process of
cognitive decline are urgently needed.
MyCognition developed a serious game called AquaSnap which might be able to
interactively improve various cognitive functions. The compliance of PD
patients might be higher compared to current therapies, due to the enjoying
storyline in the game. This may lead to better results.
Study objective
The main aim of this phase-II-proof-of-principle study is to test whether the
health game AquaSnap offers improvement of cognitive impairment in PD patients
with mild cognitive impairment, using an RCT. The long-term ambition is to test
whether the My-Cog intervention can also reduce the speed of cognitive decline,
but this requires a different test design and is dependent upon positive
findings here. Moreover, the study proposed here will provide information about
the feasibility and compliance of the intervention in an elderly population of
non-gamers with mild cognitive deficits.
Objective fMRI: The objective of the fMRI sub-study is creating a better
understanding of the mechanisms responsible for MCI and locating the changes in
various brain structures due to AquaSnap.
Study design
A randomized controlled trial. Subjects are randomized into two groups. Group A
(N=111) will play AquaSnap for 12 weeks. Group A is offered to continue
playing the game for second period of 12 weeks, but this is not obligatory.
During this second period, group B (N=111) is offered to play AquaSnap for 12
weeks.
Study Design fMRI: 20 playing subjects (Group A) and 20 controlgroup (Group B)
subjects will participate in the sub-study fMRI, which aims at providing us
with evidence for a mechanistic explanation for the effect of the intervention.
Intervention
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: psychomotor speed, executive
function, episodic memory, attention span, and working memory. Group A (N=111)
is asked to play the game at least three times a week, for at least 30 minutes
and during 12 weeks. After these 12 weeks they are allowed to continue playing
the game a second period of 12 weeks, but this is not obligatory. During this
second period, group B (control group, N=111) is offered to play the game for
12 weeks free of choice.
Study burden and risks
Subjects are neuropsychologically assessed at three moments: baseline, week 12
and week 24 (follow-up). This assessment takes about 2-3 hours to complete. The
MYCQ will be assessed at baseline, week 4, 8, 12, and 24 and will take about 30
minutes each time. All of the intervention subjects are required to play the
game for 12 weeks in a row for at least 1,5 hour a week. We do not suspect to
come across serious risks. Nonetheless, some of the subject may be sensitive to
gaming addiction. The possible benefits for participants are improvements in
cognitive functioning. The total burden will be about 27 hours.
fMRI burden and risks: Some subjects will join the fMRI sub-study. They will
have two cerebral MRI scans with a duration of about one hour each. Risks will
be prevented due to additional exclusion criteria (§10.3). However, there is a
small chance of finding a disorder in the MRI scans. This will be shared
immediately with the treating doctor.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51188.068.14 |