Frequently asked questions (FAQ)
Questions about the treatment
We have data from 13 participants who received VTS in a single session. 62% of the participants responded to VTS and showed improved voice quality that lasted for a minimum of 20 minutes after receiving VTS. At this point, we do not have any longitudinal data to conclude, whether this treatment could result in permanent improvement or not. The current study will investigate the effects of 3-month long VTS treatment on voice quality in SD.
A sensory trick - a tactile maneuver as simple as touching the neck - can alleviate abnormal dystonic neck spasms in cervical dystonia. We have preliminary evidence that VTS can function like a "sensory trick" as it stimulates the mechanoreceptors in the skin and the muscles of the laryngeal area.
The study risks are minimal, such as redness over the skin are where the vibrators are applied, as described in the consent form. We have tested over 15 people with SD so far, and we have no reason to believe that there are any risks associated with the procedure. The Human Research Protection Program of the University of Minnesota has reviewed the study and classified the vibrators as non-significant risk devices.
Questions about participation and travel
We are hoping to start testing participants by the end of February 2019. If you are interested in participation, please send an email to Dr. Naveen Elangovan (email@example.com) or call the laboratory (612-625-0107).
Participation in the clinical trial requires you to come to Minneapolis three times. The total duration of the study is 11 weeks. You will come to the lab at week 1, 6, and
We will pay for lodging for up to two nights. In addition, every participant will receive a stipend of $50 for meals per visit. Based on your home location and type of transportation, we will try to provide travel support, but cannot guarantee full reimbursement. You can discuss the details with the study coordinator.
We will start participant recruitment in February. If you qualify for study participation, we will enroll you in the study. You may begin study participation later in the year. Together with study personnel, you will identify a potential star
You do not have to forego your Botox treatment to take part in the study. However, you will have to start your participation within 7-10 days before you receive your next Botox injection. In other words, the first visit to the laboratory should occur while your Botox levels are low or depleted.
You will spend up to 4 hours in the lab during each of three in-lab sessions. You can get back home on the same day.
In-home sessions will last for half an hour on every treatment day. This includes 20 minutes of VTS, the vocalization of certain vowels, and the reading aloud of a set of sentences.
The vibrators will be removed after each treatment. You will attach the vibrators using hypo-allergenic tape on the skin above your voice box (Adam's apple). You do not have to wear them all the time.
You will have to return the equipment at the end of your treatment protocol. The VTS device will be reused to test other participants in the study. At this point, we are not allowed to sell/distribute the device to be used after the study is completed.