Important data for these biomechanical models to create a virtual look-a-like are the neural motor commands. How do individual patients control their functional movements. The tongue is an important organ in speech and swallowing and often impaired…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the measured sEMG signals and corresponding 3D
movement of the tongue. The study endpoint is when all data is gathered per
patient.
Secondary outcome
not applicable
Background summary
Head and neck cancer treatments can have serious side effects which under
circumstance can be debilitating. When tumour board members discuss possible
treatments, they often have to make important decisions with limited insight
into the extent of such consequences. As a result, patients and physicians have
to rely on the personal experience and intuition when selecting between
possible (surgical) interventions or organ sparing radiotherapy. To give
evidence-based foundations to such choices, we will construct a personalized,
detailed, high resolution functional digital model of each individual patient,
a genuine virtual look-alike. This virtual patient will combine data obtained
from medical imaging and other biomechanical technologies in one functional
model. High quality 3D animations incorporate the anatomy, physiology, and
neuron-musculature of the virtual patient.
Physicians will *apply* the curative treatment options to this virtual patient
to realize an audiovisual dynamic representation of the functional sequelae of
treatment. The virtual patient will simulate the effect on important functions,
e.g., mastication, swallowing, and audible speech in head and neck cancer. This
gives the tumour board and the patient direct access to the use of a functional
predictive tool, to realize evidence based decisions on treatment proposals.
Furthermore, it enables tailoring of the proposed treatment to the individual
patient, to improve functional outcome and decide on additional pre- and
post-treatment therapy. It will also clarify the individual functional
consequences of the proposed treatment in an audiovisual manner during the
counselling procedure. In ten years, we want to be able to construct a digital
model not only for head and neck cancer patients, but for each cancer patient
where treatments could impair mechanical functions.
These digital models will store all medical images, physiological data, and all
state-of-the-art knowledge of therapy consequences and functional side effects.
High quality 3D animations will visualize the likely outcomes of treatments,
and their development over time, to the tumour board and patients. Before
treatment, these visualizations will guide important decisions about treatment
options and selection.
Study objective
Important data for these biomechanical models to create a virtual look-a-like
are the neural motor commands. How do individual patients control their
functional movements. The tongue is an important organ in speech and swallowing
and often impaired due to surgery of tongue carcinomas. Obtaining indirect
estimates of the neural motor commands using the surface electromyography
technique is of great importance. Hopefully individual neural motor control can
be distilled. And these so called activation patterns can be used in the
biomechanical models, not only to control tongue movements in a personalized
fashion, but also to be able to calculate residual movement after therapy, when
certain nerve branches or muscles are affected. The main objective of this
study is to test the feasibility of the sEMG approach. To test whether the
acquired signals are able classify standardized tongue movements. And
eventually can control a biomechanical tongue model.
Study design
The study is an observational study
Study burden and risks
There is a minimal burden for the healthy volunteers. Only a maximum
participation of 1.5 hours will be asked of each individual in one session.
There is a small chance of an allergic reaction to medical adhesives. Therefore
beforehand the participants will be asked about allergies and the medical
adhesive will be tested on the skin of the underarm before using it
intra-orally.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
1. Age>18 years
2. Healthy volunteer
3. Written informed consent
Exclusion criteria
Allergic reaction to medical adhesives
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 | NL59701.031.16 |