Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette’s Syndrome

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Brief Title

Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette's Syndrome

Official Title

Transcranial Magnetic Stimulation for Individuals With Tourette's Syndrome

Brief Summary

      This study will evaluate the clinical efficacy of 1 Hz repetitive transcranial magnetic
      stimulation (rTMS) applied to the supplementary motor area (SMA) in Tourette's Syndrome (TS)
      patients who have not fully responded to conventional therapies. The investigators will
      collect TMS measures of motor cortex excitability to test whether rTMS restores normal levels
      of intracortical inhibition found to be deficient in TS. The investigators will administer
      neuropsychological tests to demonstrate that SMA targeted rTMS can be administered safely
      without significant impairments of cognitive or motor functioning. The investigators
      hypothesize that:

        1. Compared to sham (placebo), active rTMS will improve symptoms of TS as assessed with the
           Yale Global Tic Severity Scale (Y-GTSS) and Clinical Global Impression (CGI).

        2. Active (but not sham) rTMS will normalize levels of motor cortex excitability, as
           reflected by increased intracortical inhibition, motor threshold, and cortical silent
           period, and by decreased intracortical facilitation, relative to pre-treatment baseline.
    

Detailed Description

      This study tests the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) in the
      treatment of Tourette's Syndrome (TS). It also examines measures of brain function to study
      the brain basis underlying TS.

      Despite major advances in the study and treatment of TS, patients often do not experience
      full remission from pharmacotherapy or behavioral therapy (Leckman 2002). rTMS is a
      non-invasive procedure that stimulates the brain using magnetic fields. This pilot study
      reported that rTMS may reduce TS symptoms (Mantovani et al., 2006). While promising, prior
      research has several limitations (e.g., relatively small sample sizes, and lack of sham
      [placebo] comparison).

      This study addresses the drawbacks of prior work, and will provide data that will help to
      determine whether rTMS can be useful for TS patients resistant to conventional therapies. 25
      outpatients with TS who have been only partially responsive to conventional therapies will be
      randomly assigned to either active low frequency (1 Hz) rTMS or sham (placebo) stimulation.
      The active or sham stimulation will be applied to the supplementary motor area (SMA) daily
      for three weeks. If rTMS will be added onto ongoing pharmacotherapy, the doses must have been
      stable for four weeks prior to study entry. The SMA was selected because of its connections
      with brain areas implicated in TS. Pilot work indicates that stimulation of SMA with low
      frequency rTMS is beneficial in TS patients. Low frequency rTMS has the added benefit of a
      better safety profile (i.e. no risk of seizure) than high frequency rTMS.

      Rating scales for symptom change will be obtained at baseline, during the rTMS course, and at
      the end of three weeks of treatment. Patients will then be offered an open-label cross-over
      phase for an additional three weeks of daily active rTMS treatment. Patients who meet
      remission criteria in either phase or response criteria following the cross-over phase will
      continue routine clinical care under the supervision of their treating psychiatrist and will
      be invited back for assessment at 1, 3, and 6 months to determine the persistence of benefit.

      Excitability of the motor cortex has been reported to be abnormal in TS, and may relate to
      dysfunction in motor pathways. We will collect measures of motor cortex excitability (with
      single and paired-pulse TMS) at baseline and after each phase to study whether changes in
      these measures may be correlated with clinical improvement.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Scale (Y-GTSS)


Condition

Tourette Syndrome

Intervention

Transcranial Magnetic Stimulation (active)

Study Arms / Comparison Groups

 Active
Description:  

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 2007

Completion Date

July 2011

Primary Completion Date

July 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Primary diagnosis of Tourette's Syndrome, as confirmed by the DSM-IV-TR criteria

          -  Residual TS symptoms, defined as a total Y-GTSS total motor tic or phonic tic score >
             20, despite treatment with an adequate trial of medications (defined as a failure to
             respond to a trial of commonly used medications for TS such as clonidine, guanfacine,
             or neuroleptic medications, given at recommended dosage and duration based on the
             clinician's judgment)

          -  Persistent high level of tic severity for 4 months despite efforts to control the tics
             using medications, or the presence of self injurious tics

          -  Duration of the index episode of at least a year

          -  Individuals who cannot tolerate medications of class and dose at the specified
             duration as described above will also be included

          -  Patients currently on medication must be at the same stable dose(s) for one month
             prior to enrollment and be willing to continue at the same dose(s) through the
             duration of the study

        Exclusion Criteria:

          -  Individuals diagnosed with major depressive disorder (current) of moderate or severe
             intensity (CGI ≥ 4), bipolar disorder (lifetime), any psychotic disorder (lifetime),
             or an Axis II personality disorder; with a history of substance abuse or dependence
             within the past year (except nicotine and caffeine); or at significant acute suicide
             risk will be excluded

        Other exclusion criteria include those common to every TMS protocol:

          -  Individuals with a clinically defined neurological disorder, with an increased risk of
             seizure for any reason, with a history of treatment with TMS, deep brain stimulation
             for any disorder will be excluded

          -  Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or
             acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips,
             shunts, stimulators, cochlear implants, or electrodes) or any other metal object
             within or near the head, excluding the mouth, that cannot be safely removed will be
             excluded

          -  Current use of any investigational drug, any medications with proconvulsive action,
             such as bupropion, maprotiline, tricyclic antidepressant, clomipramine, classical
             antipsychotics, and daily use of any medications with a known inhibitory effect on
             cortical excitability measures (e.g., anticonvulsants, standing doses of
             benzodiazepines, sedative/hypnotics, and atypical antipsychotics) will not be
             permitted

          -  If participating in psychotherapy, patients must have been in stable treatment for at
             least three months prior to entry into the study, with no anticipation of change in
             frequency therapeutic sessions, or the therapeutic focus over the duration of the TMS
             trial

          -  Finally, current significant laboratory abnormality, known or suspected pregnancy,
             women who are breast-feeding or women of childbearing potential not using a medically
             accepted form of contraception when engaging in sexual intercourse will also be
             excluded.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Antonio Mantovani, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00529308

Organization ID

5480


Responsible Party

Principal Investigator

Study Sponsor

Yale University

Collaborators

 Tourette Association of America

Study Sponsor

Antonio Mantovani, MD, Principal Investigator, New York State Psychiatric Institute


Verification Date

February 2019