An explorative study to assess novel measurement methods for evaluating speech and swallowing function in healthy volunteers and patients with tongue carcinoma (stage I-II)

The goal of this study is to investigate novel measurement methods for
detecting anatomical and functional differences in speech and swallowing before
and after surgery of patients with a stage I-II tongue carcinoma. A better
understanding of the consequences after surgery is required to provide optimal
preoperative patient counselling and ultimately improve rehabilitation therapy.
3D dynamic MRI (3D-dMRI) is a promising technique to gain more insight into
speech and swallowing function. In addition, relatively new techniques, such as
manofluorography, which is a videofluoroscopy swallowing study (VFSS) combined
with high-resolution impedance manometry (HRIM), and optopalatography (OPG)
offer new avenues for assessing speech and swallowing. The integration and
evaluation of these multiple data sources can contribute to a better
understanding of the anatomical and functional outcomes after surgery of tongue
cancer.

The first part of the study aims to depict speech and swallowing function with
3D-dMRI in healthy volunteers to establish a set protocol for use in patients.
The second part of the study will investigate if anatomical and functional
differences in speech and swallowing between pre- and post-surgery situations
in patients with tongue cancer can be measured with 3D-dMRI, manofluorography,
OPG, and questionnaires.

The first part with healthy volunteers has an exploratory study design. The
second part with stage I-II tongue cancer patients is an explorative
prospective observational one-group cohort study.

The burden and risks for the healthy volunteers in this study associated with
the MRI measurements are negligible since these measurements are non-invasive
and biologically not harmful. Their involvement plays a crucial role in
providing data on the movements during speech and swallowing with unaffected
anatomy. This is essential in establishing normal values that will serve as a
reference point for the second part of the study with tongue cancer patients.
The questionnaires, preoperative MRI scan, manofluorography are part of
standard clinical care for tongue cancer patients and therefore no additional
risks are associated with participation. Furthermore, no health risks are
accompanied with OPG. The burden to the study mainly includes the time it takes
to participate. There will be five extra visits for examinations that are not
(yet) part of the standard care pathway: 1) preoperative OPG, 2) 3-months
postoperative OPG, 3) 3-months postoperative MRI scan, 4) 1-year postoperative
OPG and 5) 1-year postoperative MRI scan (see Figure 1). The added burden of
the study is the addition of study sequences to the MRI investigation while
performing speech and swallowing activities during the MRI scans, which will
increase the necessary diagnostic MRI scan time by 10 to 15 minutes.
No direct benefit is expected for participating patients. However, the
knowledge gained from this study will provide a greater understanding of tongue
function, thereby enhancing comprehension of speech and swallowing abilities in
patients. Eventually, this will lead to improvements in speech and swallowing
therapy and counseling. In addition, with further optimization of dynamic MRI,
it could serve as a favorable substitute for VFSS, eliminating the necessity
for radiation in diagnosing swallowing function. Furthermore, outcomes of the
current study could eventually contribute to a better trade-off in which part
of the tongue should be removed with the functional outcome considered and
could thus provide a benefit for these patients in general. Ultimately,
insights from this study may lead to optimized pre-operative patient
information and a better focus in their rehabilitation therapy.