Repetitive Transcranial Magnetic Stimulation to Reduce Tics

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Brief Title

Repetitive Transcranial Magnetic Stimulation to Reduce Tics

Official Title

Using Transcranial Magnetic Stimulation to Reduce Tics

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 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
    

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 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.
    


Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Scale


Condition

Tourette Syndrome

Intervention

Sham Repetitive Transcranial Magnetic Stimulation

Study Arms / Comparison Groups

 Sham Repetitive Transcranial Magnetic Stimulation
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

12

Start Date

November 2010

Completion Date

March 2013

Primary Completion Date

November 2012

Eligibility Criteria

        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.

        -

        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.

        -
      

Gender

All

Ages

10 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Steve Wu, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01258790

Organization ID

IRB #: 2010-2689


Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati


Study Sponsor

Steve Wu, MD, Principal Investigator, Cincinnati Children's


Verification Date

May 2014