Brain Activity During Attempted Movement in Late-Stage ALS: an fMRI Study

A Brain Computer Interface (BCI) allows computer control with brain activity.
This can be useful for people with severe communication impairments due to
paralysis. People most likely to benefit from BCI technology are those with
late-stage amyotrophic lateral sclerosis (ALS), since this condition may lead
to complete paralysis and an inability to speak. In earlier research, we have
shown that people with severe motor impairment are able to generate signal
changes in the sensorimotor hand area by attempting to move their hand
(Freudenburg et al, 2019) and that these signals can be used to produce *brain-
clicks* that can be used to select letters on a computer screen (Vansteensel et
al., 2016). To allow for faster BCI-based communication, more degrees of
freedom are necessary, which can be accomplished by extracting and
distinguishing multiple control signals from the sensorimotor area. Here, we
will investigate to what extent brain activity from sensorimotor cortex during
the attempt of different course and fine movements in people with late-stage
ALS can be differentiated. We will use fMRI to measure brain activity and asses
feasibility of decoding different movements (individual fingers and courser
movements of the hand and other body parts) based on that brain activity. As a
check for a potential confounding effect of muscle activity on brain activity,
we will also measure EMG during the fMRI scan. We will compare the decoding
accuracy from people with late-stage ALS with that of age- and gender- matched
controls.

The purpose of this study is to assess the feasibility of decoding multiple
movements from sensorimotor cortex of people with late-stage ALS and healthy
controls.

This study is observational and uses fMRI to assess brain activity in people
with late-stage ALS and age- and gender- matched healthy control participants.

Risks and Burden of fMRI
For healthy controls, risks and burden of the fMRI scan in this study are
minimal.
For people with late-stage ALS, participating in the fMRI scan can be somewhat
more burdensome due to practical difficulties (not being able to move).
Moreover, in general, people with ALS may experience discomfort due to
respiratory and saliva difficulties while lying down. For people who are
artificially ventilated, the necessary transfer to MR compatible ventilation
equipment may be somewhat uncomfortable. Due to the particular state of these
participants, additional attention to safety measures will be in place, such as
a constant channel of communication with a researcher or caregiver throughout
the scanning session. Also, the presence of strict inclusion criteria (e.g.
being able to lay flat during the entirety of one hour of scanning session), a
pre-scan clinical evaluation and the presence of a clinician during the MRI
session assures that included patients have maximum safety and minimum
discomfort during the study. Since trained medical professionals will be
responsible for screening and monitoring and for caring for the participants,
the risk associated with the fMRI scan will also be minimal for ALS patients.
More details about potential issues people with ALS may experience can be found
in section 11.4 of C1.
Risks and Burden of EMG
All participants will undergo an EMG measurement of arm muscles (to asses
potential confounding effect of muscle activity on brain activity) during the
fMRI scan. There are no risks associated with EMG measurement and the burden is
minimal.