MdDS Reset VORtex is subject of a clinical trial which is starting in Antwerp. Scientific partners in this trial are:
The clinical trial aims to investigate whether a virtual reality application (MdDS Reset VORtex) is able to improve MdDS symptoms or complaints compared to the “golden standard” (the OKN booth).
The clinical trial will be executed by Catho Schoenmaekers, PhD student, under the supervision of Prof. Dr. Floris Wuyts, Head of the Lab for Equilibrium Investigations and Aerospace (LEIA), both at the Antwerp University hospital and at the European Institute for ORL-HNS of the Sint-Augustinus Hospital, Wilrijk.
The study will focus not only on the comparison with the existing treatment, MRI-scans will also be taken before and after treatment to investigate the effect of both OKN treatments. By the use of MRI scans, the investigators will be able to unravel the underlying pathophysiological mechanism of MdDS and further provide more efficient treatment options.
We are very excited about this clinical trial and are looking forward to co-operate with LEIA, at the University of Antwerp, to ensure better relief for MdDS Reset patients and give them back control of their own lives.
A summary of the protocol that will be followed:
MdDS patients have an internal sensation of moving back and forth continuously or for most of the day, similar to the feeling of sitting on a boat. They have the sensation of being in movement while perfectly sitting still or lying down. The movement in different directions are referred to as swaying (left-right), bobbing (up and down) and/or rocking (forward-backward). MdDS patients test normal on functional peripheral vestibular tests which may give rise to the idea that the development of MdDS arises at the level of the cortex cerebri, the brain. MdDS is underdiagnosed and only very recently recognised as a vestibular disorder.
The participants, MdDS patients, will be divided into 2 treatment groups: treatment group 1 (T1) will be treated with the virtual reality application (MdDS Reset VORtex) and treatment group 2 (T2) with the OKN booth. Both treatments are based on the same non-invasive principle that is seen as the "standard of care" with already good results or in other words a significant reduction to the disappearance of the internal oscillatory sensation. The principle is based on the combination of, firstly, a moving stripes pattern which will provide an optokinetic stimulation that will fill the full field of view (full field optokinetic stimulation). The stripes move in different directions, moving to the right, to the left, up or down. Second, the head of the participant will be tilted from shoulder to shoulder by the clinician for 4 minutes (= roll movement). The specific frequency at which the head is tilted is the resonant frequency of the vestibular system, 0.167 Hz being an oscillation with a period of 6 seconds.
The difference between the two treatment groups is that T1 will be presented with the stripes pattern in a virtual reality environment, while T2 will see them projected in a booth. For both groups, the participant will be treated during 4 consecutive days. A day treatment consists of 2 sessions (morning and evening) of 2 x 4 minutes each. Additional tests are an audiogram, VNG, posturography, Unterberger's stepping test, well-being questionnaires and MRI brain scans.
If you suffer from MdDS and want to get in touch with the research team (whether or not you want to participate in the trial), here's how you can get in contact:
Next to this study, we are open for other research opportunities, so if you would be interested, please feel free to contact us and mention your interest.