Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette's Syndrome

Tourette Syndrome Clinical Trial

Official title: An Open Label, One Arm Pilot Study to Measure the Efficacy and Safety of Dysport in the Treatment of Vocal Tics in Patients With Tourette's Syndrome and Chronic Tic Disorders

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The intervention for this pilot study will be the injection of Dysport (Abobotulinum toxin A) into the affected vocal cords for all patients with the diagnosis of Primary Tourette's syndrome. A total of 5 units of Dysport (on each side) will be administered to patients diagnosed with TS to determine whether they exhibit a reduction in the number of vocal tics. The patients will complete a self assessment survey about the manner in which the vocal tics are affecting their daily lives. Further evaluation of the tics will be conducted by the investigator using the Yale Global Tic Severity Scale (YGTSS) evaluation.

The intervention will be completed by a licensed ENT (Ears Nose and Throat) physician. The procedure will be conducted in an outpatient clinic setting because no hospitalization is required for this study. The windpipe will be numbed by a 2% lidocaine followed by a provoked cough by the patient. This will enable the lidocaine to be sprayed throughout the airway preventing any coughs or swallowing during the main intervention procedure. Under Electromyography (EMG) guidance a needle containing Dysport will be injected into the thyroarytenoid muscles which will potentially reduce the vocal dyskinetic features in individuals with TS. The needle containing Dysport will be connected to a syringe and once it is determined it is active, it will be placed appropriately when the EMG emits a characteristic sound. A total of 5 units of Dysport (2.5 units on each side) will be administered to the patient. 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.

The patient will not be allowed to consume food or drink for approximately 45-60 minutes after Dysport has been injected. The throat will be numb after the anesthetic and may cause coughing and some blood tinged sputum which is expected and hence will not be considered a serious event. The patient will not be allowed to consume aspirin or ibuprofen a week prior to and till the intervention for at least 3-4 days after the intervention to prevent excessive bleeding. The patient will also be provided with specific instructions 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 (Day 1), after the patient has completed all the required study documents and forms, the ENT physician will proceed with the injection of Dysport on the same day. However, if due to unforeseen circumstances, the subject cannot be injected on the same day, the intervention must take place within three days and this will be considered V1 (Day 1) and all follow up visits should be scheduled accordingly. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Vocal Tic
• Syndrome
• Tics
• Tourette Syndrome

• NCT number: NCT02187679
• Study type: Interventional
• Source: Detroit Clinical Research Center
• Contact: Kimberly Rooker, BS
• Phone: 248-716-7009
• Email: kimberly.Rooker@dcrc.us
• Status: Recruiting
• Phase: N/A
• Start date: January 2014