Multiple Screening: a tool to identify cognitive deficits in individuals with Multiple Sclerosis in an early stage. The acquisition of normative data.

50-70% of the individuals suffering from multiple sclerosis (MS) experience
cognitive deficits. Although these problems result into a decrease in quality
of life, the physical problems are often more apparent and require priority
during an appointment with the neurologist. To ensure a fast diagnosis of the
cognitive problems in MS patients as well, a quick, reliable cognitive
evaluation is needed. An evaluation that may help the neurologist to set out
certain treatment plans.

The Brief International Cognitive Assessment for MS (BICAMS) is a well-known
international neuropsychological test battery. The battery is short (15
minutes) and reliable (the tests within this battery measure the most affected
cognitive domains in individuals with MS). However, a test administrator
(neuropsychologist or MS-nurse) is still needed for execution of the BICAMS,
which will hold back the actual administration of this cognitive test battery.
In an ideal situation the patients would have already performed the test
battery before entering the room of the neurologist. The purpose of this study
will be the development of a digital BICAMS in which the patients will be able
to perform the tests independently, and the outcomes of the tests will be send
directly to the neurologist. In order to generate a result of the test scores
for the MS patients, norm scores need to be obtained and implemented in the
digital test battery. This specific sub-question is the objective of the
proposed study, which will take place via a two-steps model:
Aim 1) Evaluate the digital BICAMS app (Multiple Screening) according to
understandability, feasibility, and independence in a small group of
individuals with MS; 2) Obtain normative data for the digital cognitive tests
using a group of healthy volunteers, of which the first group (N=60) will also
do the paper-and-pencil version of the tests for validation purposes.

The purpose of the current study:

Aim I
To investigate the understandability, feasibility, and independence of an
already manufactured digital cognition tool (Multiple Screening app) in
individuals with MS. The patients will be asked to evaluate the app via a
questionnaire, which enables us to ensure independent use of the app in MS
patients. Possible improvements to the app will be integrated before using the
app in acquiring normative data. The evaluation questionnaire is added to the
protocol (see appendix on page 50), and subsequently, a short interview will
follow to be certain everything about the Multiple Screening tool will be
discussed.

Aim II
A group of healthy participants (N=250) will execute the digital BICAMS via an
app on an iPad to acquire normative data of the digital cognitive tests. The
obtained norm scores will be integrated in the Multiple Screening app, which
will eventually be used to put the scores of an MS patient directly into
perspective. Sixty healthy volunteers will perform both the digital as the
paper-and-pencil version of the test to investigate whether we are allowed to
compare the scores on both tests directly. Half of the participants (N=30) will
first perform the paper-and-pencil version and the digital version after. The
other half will perform the digital version first, following the
paper-and-pencil version. A parallel version of the neuropsychological tests
that are integrated in the Multiple Screening app will be used for the
paper-and-pencil tests.

Aim I
Fifteen MS patients will execute the Multiple Screening app on the iPad in an
enclosed area. Subsequently, they will be asked to evaluate the Multiple
Screening app via an evaluation questionnaire (see appendix on page 50).
Afterwards, a short interview of 10 minutes will take place. The appointment
will last approximately 30 minutes in total. Genzyme Sanofi and the app
developers will be informed about the outcomes of the evaluation questionnaire.
The cognitive domains that will be investigated are information processing
speed, visual memory, and verbal memory. After integrating the improvements in
the app, we expect that the Multiple Screening app is suitable to be used by
the regular individual with MS. To verify this, we will test the improved
Multiple Screening app again in 5 independent (not tested before) MS patients.
We will optimize the app again when problems occur during the second test
phase. Although we do not expect this to occur.

Aim II
For this phase of the study, N=250 healthy participants execute the Multiple
Screening app in an enclosed area with the purpose of acquiring normative data.
This will take approximately 15 minutes for the participant. We will also
administer the paper-and-pencil version of the tests to the first 60
participants to investigate whether the scores on both methods can be used
interchangeably.

For this study, both the MS patients as the healthy participants will be tested
only once. The MS patients will be asked to execute the Multiple Screening app
on an iPad, to fill in an evaluation questionnaire, and to do a short interview
of approximately 10 minutes. Altogether, the appointment will last for about 30
minutes. When the Multiple Screening app is fully optimized, healthy
participants will be asked to be available for 15 minutes to perform the
Multiple Screening on the iPad. The first sixty participants will also perform
the paper-and-pencil version of the test, to be able to compare the scores of
both test versions. As this study is only asking the participants to work with
an iPad, and no intervention is being investigated, will let us to conclude
that it will be unlikely that the participants are at risk for any damage.