Ignite Creation Date:
2024-05-06 @ 3:01 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02187679
Status:
UNKNOWN
Last Update Posted:
2015-02-10
First Post:
2014-07-09
Brief Title:
Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourettes Syndrome
Sponsor:
Detroit Clinical Research Center
Organization:
Detroit Clinical Research Center
Study Overview
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 Tourettes Syndrome and Chronic Tic Disorders
Status:
UNKNOWN
Status Verified Date:
2015-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our intervention will be the injection of Abobotulinum toxin A into the affected sitevocal cords for patients with the diagnosis of Primary Tourettes 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 25 units of Dysport on each side of the affected vocal cords for patients with a diagnosis of Primary Tourettes 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
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
Detailed 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 Tourettes 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 25 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
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 25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None