An interventional study of Sham Repetitive Transcranial Magnetic Stimulation and Active Repetitive Transcranial Magnetic Stimulation in Tourette Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-07-01.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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
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 two medications are FDA-approved for tic treatment, while many more are used in an off-label fashion with only partial success. Despite multiple approaches for tic suppression, patients with severe tics are often left with inadequate relief. Repetitive Transcranial Magnetic Stimulation (RTMS) is a new technology which allows for noninvasive stimulation of the brain. In few pilot studies, RTMS reduced tic severity when targeting the Supplementary Motor Area (SMA). In this study, we propose to use a specific paradigm of RTMS called Continuous Theta Burst Stimulation (cTBS) over SMA to treat pediatric and adult patients with tics. We will utilize functional MRI (fMRI) to identify each subject's SMA for individualized stimulation. We hypothesize that this stimulation technique can reduce tic severity when compared to sham stimulation. This proposal is novel because 1) cTBS is offered as a new RTMS paradigm to reduce tics and 2) combination of RTMS and fMRI allows us to investigate the effects of cortical stimulation on the neural correlates of tic generation.
220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.
This study's enrollment of 12 is below the median of 34 across 166 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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Inclusion Criteria:1. Children or adults with Tourette Syndrome, tic disorder, chronic motor or vocal tics disorder ages 10 to 60 years.
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Exclusion Criteria:1. Implanted brain stimulator, vagal nerve stimulator, VP shunt, aneurysm clip, cardiac pacemaker, or implanted medication port.
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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.
Device: Sham 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.
Device: Active Repetitive Transcranial Magnetic Stimulation
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.
Also known as: rTMS, TBS, TMS
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.
Also known as: rTMS, TBS, TMS
Yale Global Tic Severity Scale
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.
Time frame: 1 week
| Milestone | Active Repetitive Transcranial Magnetic Stimulation | Sham Repetitive Transcranial Magnetic Stimulation |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
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.
| units on a scale (0 - 50) | Active Repetitive Transcranial Magnetic Stimulation | Sham Repetitive Transcranial Magnetic Stimulation |
|---|---|---|
| Yale Global Tic Severity Scale | 23.2 ± 9.8 | 21.7 ± 7.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Repetitive Transcranial Magnetic Stimulation | — | 0/6 (0%) | 2/6 (33.3%) |
| Sham Repetitive Transcranial Magnetic Stimulation | — | 0/6 (0%) | 1/6 (16.7%) |
| Event | Active Repetitive Transcranial Magnetic Stimulation | Sham Repetitive Transcranial Magnetic Stimulation |
|---|---|---|
| Mild headacheNervous system disorders | 1/6 | 1/6 |
| Mild abdominal discomfortGastrointestinal disorders | 1/6 | 0/6 |
| Age, Continuous(years) | Active Repetitive Transcranial Magnetic Stimulation | Sham Repetitive Transcranial Magnetic Stimulation | Total |
|---|---|---|---|
| Mean | 13.5 ± 3.9 | 15.5 ± 4 | 14.5 ± 3.9 |
| Sex: Female, Male(Participants) | Active Repetitive Transcranial Magnetic Stimulation | Sham Repetitive Transcranial Magnetic Stimulation | Total |
|---|---|---|---|
| Female | 0 | 3 | 3 |
| Male | 6 | 3 | 9 |
| Yale Global Tic Severity Scale(units on a scale (0 - 50)) | Active Repetitive Transcranial Magnetic Stimulation | Sham Repetitive Transcranial Magnetic Stimulation | Total |
|---|---|---|---|
| Mean | 27.5 ± 7.4 | 26.8 ± 4.8 | 27.2 ± 6.0 |
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Children's Hospital Medical Center, Cincinnati