Combined CBIT and rTMS to Improve Tourette’s Syndrome

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Brief Title

Combined CBIT and rTMS to Improve Tourette's Syndrome

Official Title

STOP-TIC Study: Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT

Brief Summary

      The investigator will apply 16 sessions of repetitive transcranial magnetic stimulation
      (rTMS) over 4 consecutive days for adult patients suffering from Tourette's Syndrome.
      Following rTMS, patients will undergo 8 sessions of Comprehensive Behavioral Intervention for
      Tics (CBIT) over 10 weeks via telemedicine. Clinical improvement in tic severity will be the
      primary outcome measure. Secondary outcome measures including underlying physiological
      effects will be measured via functional magnetic resonance imaginge (fMRI), high-density
      electroencephalograhy (HD-EEG), and TMS.
    

Detailed Description

      Patients will be randomly assigned to active or sham stimulation, with 10 in each group,
      followed by 10 weeks of tele-CBIT. Patients will have primary and secondary outcome measures
      performed at four time points: Baseline (T0), following rTMS (T1), following CBIT (T2), and 1
      month later (T3). The rTMS protocol will consist of 6 trains targeted to the supplementary
      motor area (SMA) lasting 5 minutes each (300 pulses per train) with an intertrain interval of
      1 minute for a total duration of 35 minutes (1800 pulses). Patients will receive 4 sessions
      each day on 4 consecutive days for a total of 16 sessions. Daily duration of this study
      protocol should last approximately 170 minutes including a 10 minute break in between each
      session. The sham protocol will be the same except a sham coil will be used instead of an
      active coil. Following rTMS, patients will undergo 10 weeks of tele-CBIT.

      The following outcome measures will be collected at four timepoints (T0, T1, T2, and T3):

      Tics will be examined with the standardized Yale Global Tic Severity Scale (YGTSS) and the
      modified Rush Videotape Tic Rating Scale (mRVTRS), and co-morbid symptoms with the Beck
      Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Yale-Brown Obsessive Compulsive
      Scale (Y-BOCS) and Adult ADHD Self-Reports Scale (ASRS). Quality of life will be assessed
      with the Gilles de la Tourette Syndrome - Quality of Life scale (GTS-QOL).

      TMS measures: A single-pulse of TMS will be targeted over the motor cortex to generate a
      motor evoked potential (MEP), which can be captured on EMG. The rest of the EMG will be
      analyzed to assess the time between the TMS pulse and the MEP (also known as the latency) and
      the amount of time muscle activity remains silent following the MEP (also known as the
      cortical silent period). In a paired-pulse TMS paradigm, a subthreshold pulse will be
      provided followed by an interstimulus interval and then subsequent delivery of a
      suprathreshold pulse. When the interstimulus interval is short (1-4 msec), the ratio of MEP
      amplitudes produced by these two pulses is known as short interval intracortical inhibition
      (SICI).

      fMRI measure: Functional MRI will be used to record Blood Oxygen Level Dependent (BOLD)
      activity changes in patients at rest.

      HD-EEG measure: A 128-electrode cap will be used to assess electrical activity in patients at
      rest and actively trying to suppress their tics.
    


Study Type

Interventional


Primary Outcome

Tic severity

Secondary Outcome

 Modified Rush Videotape Tic Rating Scale (mRVTRS)

Condition

Tourette Syndrome

Intervention

Transcranial Magnetic Stimulation

Study Arms / Comparison Groups

 Active rTMS Group
Description:  Patients will be seated in a comfortable reclined chair. The neurostimulation protocol will include 1-Hz rTMS over the bilateral SMA at 110% resting motor threshold (RMT). The SMA will be identified as 4 cm anterior to the vertex (Cz in standard 10-20 EEG setup). Each session will consist of 6 trains lasting 5 minutes each (300 pulses per train) with an intertrain interval of 1 minute for a total duration of 35 minutes (1800 pulses). Patients will receive 4 sessions each day on 4 consecutive days for a total of 16 sessions. Daily duration of this study protocol should last approximately 170 minutes including a 10 minute break in between each session.

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

30

Start Date

September 2021

Completion Date

September 2022

Primary Completion Date

September 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Any patient diagnosed with Tourette Syndrome > 18 years of age with moderate tic
             severity.

          -  Participants will be allowed to continue oral medications that they are taking for TS
             concurrently but will not be allowed to change their concurrent medication regimen
             throughout the duration of the study

        Exclusion Criteria:

          -  Presence of metallic objects or neurostimulators in the brain

          -  Pregnancy

          -  History of active seizures or epilepsy

          -  Contraindications to receiving fMRI, such as claustrophobia

          -  Inability to participate in CBIT due to other underlying cognitive or medical
             condition
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Jessica Frey, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04795908

Organization ID

IRB202002701-A


Responsible Party

Sponsor

Study Sponsor

University of Florida


Study Sponsor

Jessica Frey, MD, Principal Investigator, University of Florida


Verification Date

July 2021