Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome

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Brief Title

Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome

Official Title

Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome

Brief Summary

      The investigators are investigating the effectiveness of a wearable multisite transcranial
      magnetic stimulation (mTMS) device that can deliver stimuli at multiple cortical sites
      simultaneously or sequentially for the treatment of Tourette Syndrome.
    

Detailed Description

      STUDY OBJECTIVES/HYPOTHESIS

      Tourette Syndrome (TS) is a neurodevelopmental condition that affects nearly 1% of children
      world-wide. While it can be treated with drugs and behavioral therapy, other modalities are
      being sought, especially, in cases that are resistant to standard treatment. One such
      approach that is being tested in pilot clinical studies is repetitive transcranial magnetic
      stimulation (rTMS). Noninvasive magnetic stimulation of the cerebral cortex is an important
      and useful technique in neuroscience research, as well as in diagnostic and therapeutic
      clinical investigations. Over the last three decades the magnetic stimulation procedure is
      being carried out using a device called transcranial magnetic stimulator (TMS), which uses a
      large hand-held electromagnetic coil passing high amplitude current to induce a rapidly
      changing magnetic field at a single cortical site. TMS has found clinical application in
      several neurological and psychiatric conditions such as stroke, major depression, migraine,
      movement disorders and Tourette syndrome. One limitation of conventional TMS, besides the
      bulkiness of the device and the large amount of current involved, is that it allows
      stimulation at only one cortical site at a time. Dr. Santosh Helekar of Houston Methodist
      Research Institute (HMRI) and Dr. Henning Voss of Weill-Cornell Medical College (WCMC) have
      developed a compact portable and wearable multisite transcranial magnetic stimulation (mTMS)
      device that can deliver stimuli at multiple cortical sites simultaneously or sequentially. It
      uses rapidly rotating small high strength permanent magnets to induce currents in the brain.
      As opposed to conventional TMS, the mTMS device is also ideally suited to conduct
      double-blind placebo-controlled studies because undetectable demagnetized magnets can be
      intermixed with actual magnets to allow rapid rotation of either type of magnets to be
      activated in one and the same device in a randomized protocol. Under a previously approved
      HMRI study protocol this new device has been shown to induce motor-evoked potentials (MEPs)
      in thenar muscles by highly focused stimulation of their cortical representation in the
      precentral gyrus.

      In the present pilot study, the investigators would like to conduct a randomized double-blind
      placebo-controlled clinical trial to test the therapeutic effectiveness of bilateral mTMS
      stimulation of the supplementary motor areas (mTMS-SMA therapy) in TS patients presenting
      with tics uncontrolled by standard drug and behavioral treatment. The specifics aims of this
      study are:

        1. To compare the immediate benefits obtained by TS patients subjected to two weeks of five
           day per week mTMS-SMA therapy with respect to those obtained by TS patients receiving
           placebo (sham stimulation) treatment, in terms of reduction of the frequency of tics and
           alleviation (primary end points) and of other comorbidities (ADHD and OCD, secondary end
           points) of TS.

        2. To compare the long-term benefits as above over a two-month follow up period in the same
           set of treated and placebo control TS patients

      The investigators will conduct this study in 20, English speaking, TS patients in the age
      range of 8 to 20 years. Half the patients will be randomly assigned in a double-blind manner
      to the active treatment or the placebo control (sham treatment) groups that will be
      appropriately age-and gender-matched. Randomization will be completed by the study team by
      alternating between cap A and cap B, within specific cohorts. The cohorts will be as follows:
      8-13 years of age at time of enrollment and 14-20 years of age at time of enrollment. The
      stimulus parameters used will be those that are effective in upregulating the excitability of
      the motor pathways to elicit MEPs in the thenar muscles. The investigators believe that
      mTMS-SMA therapy will produce both short- and long-term benefit for TS patients.
    


Study Type

Interventional


Primary Outcome

Change in tic severity from baseline to 2 months post-treatment

Secondary Outcome

 Change in ADHD symptoms from baseline to two months post-treatment

Condition

Tourette Syndrome

Intervention

Active Treatment

Study Arms / Comparison Groups

 Active Treatment Group
Description:  Each patient will receive daily 40 min treatment five days per week for two weeks. The procedure during each treatment session will consist of positioning the device centered at 15% of the nasion-inion distance anterior to the Cz electrode placement in standard EEGs, with the patient relaxing in a chair.
The stimulus parameters used will be 480 stimulus trains of 100 ms in duration, each train delivered every 5 s for total session duration of 40 min. The investigator will measure the subject for accurate placement of the device prior to each visit. Once the placement of the device is confirmed, the study technician administering the treatment will tum on the device using an app downloaded to an electronic device connected by Bluetooth to the device.

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

20

Start Date

July 1, 2019

Completion Date

June 2022

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients between the ages of 8 and 20 years old,

          -  A clinical diagnosis of TS as defined by the DSM V

          -  YGTSS score of 13 or more (performed at Visit 1).

          -  Patients with the following comorbidities: OCD, ADHD and anxiety disorders (as defined
             by the DSM V) will be allowed in the study. This will be assessed during Visit 1.

          -  The patients may be on medications for the treatment of TS or allowed comorbidities
             provided the medication regimen is stable for six weeks prior to inclusion in the
             study and remains unchanged for the 10 weeks that the study will last.

        Exclusion Criteria:

          -  Any history of neurological, or psychiatric disorders including epilepsy and autism
             spectrum disorder, other than other than the allowed comorbidities (see above).

          -  An IQ less than 80, this will be assessed during Visit 1.

          -  Any changes in medications prescribed for the treatment of TS or allowed comorbidities
             six weeks prior to inclusion in the study or at any time during the study.

          -  The presence of metal implants or metallic devices in the head

          -  Any history of drug or alcohol abuse

          -  Any medication changes during the six weeks preceding enrollment or at any time during
             the 10-week course of the study
      

Gender

All

Ages

8 Years - 20 Years

Accepts Healthy Volunteers

No

Contacts

Keith A Coffman, M.D., 816-302-3320, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03642951

Organization ID

14050210


Responsible Party

Sponsor

Study Sponsor

Children's Mercy Hospital Kansas City

Collaborators

 The Methodist Hospital Research Institute

Study Sponsor

Keith A Coffman, M.D., Principal Investigator, Children's Mercy Hospital Kansas City


Verification Date

January 2021