- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258790
Repetitive Transcranial Magnetic Stimulation to Reduce Tics
Using Transcranial Magnetic Stimulation to Reduce Tics
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 stimulation, will reduce tic severity by at least 25% as measured by the Yale Global Tic Severity Scale
Specific Aim2: Using cTBS to further understand neural correlates of tic generation
Hypothesis2: Functional MRI BOLD signal activation pattern will change after cTBS and this change will correlate with clinical improvement in tic severity
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:1. 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 Criteria:1. 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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Sham Comparator: Sham Repetitive Transcranial Magnetic Stimulation
Eight sessions of Repetitive Transcranial Magnetic Stimulation, in the form of Continuous Theta Burst Stimulation, was delivered over the Supplementary Motor Area over 2 days using a Sham TMS coil.
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Repetitive Transcranial Magnetic Stimulation (RTMS) is a relatively new technology that allows for targeted noninvasive stimulation of the brain.
RTMS is currently FDA-cleared for the treatment of refractory depression.
It is also used experimentally to treat seizures, spasticity, dystonia and other neuropsychiatric conditions.
The Sham intervention uses a sham magnetic coil.
Other Names:
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Experimental: Active Repetitive Transcranial Magnetic Stimulation
Eight sessions of Repetitive Transcranial Magnetic Stimulation, Continuous Theta Burst Stimulation, was delivered over the Supplementary Motor Area over 2 days using an Active Magstim Figure-8 TMS coil.
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Repetitive Transcranial Magnetic Stimulation (RTMS) is a relatively new technology that allows for targeted noninvasive stimulation of the brain.
RTMS is currently FDA-cleared for the treatment of refractory depression.
It is also used experimentally to treat seizures, spasticity, dystonia and other neuropsychiatric conditions.
The Active intervention uses an active magnetic coil.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Yale Global Tic Severity Scale
Time Frame: 1 week
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The tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50.
A person who has no tics would have a score of 0. High score means a person has severe tics.
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1 week
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Collaborators and Investigators
Investigators
- Principal Investigator: Steve Wu, MD, Cincinnati Children's
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #: 2010-2689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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