Status:
COMPLETED
Repetitive Transcranial Magnetic Stimulation to Reduce Tics
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Tourette Syndrome
Eligibility:
All Genders
10-60 years
Phase:
NA
Brief Summary
Specific Aim1: Using a paradigm of Transcranial Magnetic Stimulation called Continuous Theta Burst Stimulation (cTBS) to reduce tics in Tourette Syndrome subjects Hypothesis1: cTBS, compared to sham ...
Detailed Description
Tourette syndrome (TS) is characterized by multiple motor and phonic tics. Current understanding of tic generation is thought involve the cortico-basal-thalamic-cortical circuit. At this time, only tw...
Eligibility Criteria
Inclusion
- Children or adults with Tourette Syndrome, tic disorder, chronic motor or vocal tics disorder ages 10 to 60 years.
- 2\. Current tics with Yale Global Tic Severity Scale (YGTSS) score \> 10. 3. If subject is on tic-suppressing medication(s) at the time of recruitment, no medication or dose changes allowed within the past seven days.
- 4\. If subject receives botulinum toxin injection for tic management, the injection must be at least twelve weeks prior to the day of the study.
- 5\. After the TBS sessions, no tic-suppression medications can be changed for at least one week.
- 6\. All patients ages 10 to 60 years old with Tourette Syndrome, tic disorder, chronic motor or vocal tics disorder will be offered to participate in the study. If the patient decides to participate in the study, our study coordinator will obtain informed consent from the adult participant, or at least one parent of the pediatric participant. The consent form is written in English; the form is also written in a manner understandable by the person signing the form. The adult participant, the parent(s) of participant or the pediatric participant does not have to make a decision at the time of clinic visit, thus, minimizing coercion to participate.
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Exclusion
- Implanted brain stimulator, vagal nerve stimulator, VP shunt, aneurysm clip, cardiac pacemaker, or implanted medication port.
- 2\. Prior ischemic or hemorrhagic stroke or traumatic brain injury. 3. History of seizure or epilepsy 4. If female, pregnant or sexually active and not using birth control. Abstinence will be permitted at the discretion of the TS clinicians, consistent with other IRB approved studies involving this population.
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Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01258790
Start Date
November 1 2010
End Date
March 1 2013
Last Update
July 1 2014
Active Locations (1)
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1
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229