Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette's Syndrome
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Our intervention will be the injection of Abobotulinum toxin A into the affected site/vocal
cords for patients with the diagnosis of Primary Tourette's syndrome. This is an efficacy
trial to understand the right dosage of Abobotulinum toxin A which can be affective. The
study will involve an injection of 2.5 units of Dysport on each side of the affected vocal
cords for patients with a diagnosis of Primary Tourette's syndrome. The patients will also
complete a self assessment survey on how vocal tics affect their daily lives. Afterward, a
further evaluation of the tics will be conducted by the investigator using the Yale Global
Tic Severity Scale. (YGTSS) evaluation. How this will be done is by a licensed ENT (Ear, Nose
and Throat) physician. The windpipe will be number by a 2% lidocaine followed by a provoked
cough by the patient. This will allow the lidocaine to be sprayed throughout the airway
preventing coughing and swallowing during the procedure. An Electromyography (EMG) guidance a
needle containing Dysport will be injected into the thyroarytenoid muscles will potentially
reduce the vocal dyskinetic features in patients with TS. This needle will be connected to a
syringe and once determined active, it will be placed appropriately when the EMG emits a
characteristic sound. If this does not occur with the patient then the injection will be
administered under direct vision via direct laryngoscopy using an orotracheal injector
system.
This procedure is conducted in an outpatient clinic because no hospitalization is required.
The patient is not allowed to consume food or drink for about 45-60 minutes after the
injection. The throat will be numb and may cause coughing and some blood tinged sputum: The
expectancy of this outcome is reason to not consider is a serious event. Asprin and ibuprofen
is not allowed a week prior to and until the injection at least 3-4 days after to prevent
excessive bleeding. The patient is also instructed to ensure that they chew their food
thoroughly and drink sufficient water for the initial days after the study intervention. Mild
dysphasia may be noted initially which should resolve within a few hours. On Visit 1, the
patient will complete all required study documents and forms. Then the ENT physician will
proceed with the injection Dysport on the same day. If unforeseen circumstances render the
subject unable to be injected on the same day, the intervention must take place within three
days and this will be considered V1, follow up events should be scheduled accordingly.
Phase:
N/A
Details
Lead Sponsor:
Detroit Clinical Research Center
Collaborator:
Ipsen
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA