N/A
N=12
Repetitive Transcranial Magnetic Stimulation to Reduce Tics
Tourette Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01258790 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Yale Global Tic Severity Scale — 23.2; 21.7 units on a scale (0 - 50)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sham Repetitive Transcranial Magnetic Stimulation (Device); Active Repetitive Transcranial Magnetic Stimulation (Device)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale Global Tic Severity Scale |
23.2; 21.7 | — |
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 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
Eligibility Criteria
Inclusion Criteria:1. Children or adults with Tourette Syndrome, tic disorder, chronic motor or vocal tics disorder ages 10 to 60 years.
- 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.
- If subject receives botulinum toxin injection for tic management, the injection must be at least twelve weeks prior to the day of the study.
- After the TBS sessions, no tic-suppression medications can be changed for at least one week.
- 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.
- 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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Data sourced from ClinicalTrials.gov (NCT01258790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.