Median Nerve Stimulation (MNS) Pilot

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Brief Title

Median Nerve Stimulation Pilot

Official Title

Peripheral Induction of Inhibitory Brain Circuits to Treat Tourette's: Pilot

Brief Summary

      Results from the University of Nottingham suggested that rhythmic median nerve stimulation
      (MNS) improves tic symptoms in Tourette syndrome (TS). The investigators will (1) provide a
      first replication of their study, (2) test the hypothesized electrophysiological mechanism
      and rule out a placebo effect as cause for the symptomatic benefit, and (3) gather
      information on the duration of effect after the end of stimulation and on individual
      characteristics that predict improvement with simulation. Completion of these Aims will give
      a clear go/no-go signal for a future clinical trial of chronic MNS delivered by a
      yet-to-be-developed wristwatch-style device.

      NOTE: This study is not intended to evaluate a specific device for future use. Rather it is a
      study to determine the action of pulsed electrical stimulation on tic symptoms and to gain
      early evidence of effectiveness. This is a non-significant risk device study.
    

Detailed Description

      Chronic tic disorders (CTD), including Tourette syndrome (TS), are associated with a
      substantially reduced quality of life. Medication treatments are no more than 50-60%
      effective in randomized controlled trials, and are often discontinued due to unacceptable
      side effects. Behavioral therapies require ability to participate in therapy and a specially
      trained therapist, but weekly visits to psychologists are impractical for many Americans,
      especially in rural areas. Patients strongly desire new treatment options.

      In June, 2020, Stephen Jackson's group at the University of Nottingham published a
      fascinating report in Current Biology on a potential novel treatment for tics. The radical
      new idea arose from observations associating movement inhibition with 8-14 Hz activity in
      motor cortex. They first showed that rhythmic 12 Hz peripheral stimulation of the median
      nerve evoked synchronous contralateral EEG activity over primary sensorimotor cortex, whereas
      arrhythmic stimulation at the same mean rate did not. As hypothesized, median nerve
      stimulation (MNS) at 12 Hz created small but statistically significant effects on initiation
      of voluntary movements. Importantly, they also demonstrated that this stimulation did not
      meaningfully impair concentration, suggesting that the effect did not operate through simple
      distraction. They went on to test 10 Hz MNS in 19 TS patients, and demonstrated using blinded
      video ratings a significant reduction in tic number and severity during 1-minute stimulation
      epochs vs 1-minute no-stimulation epochs. They noted that in some participants, benefit
      lasted beyond the end of the stimulation epoch. Videos accompanying the publication showed
      dramatic benefit during MNS in some subjects. Although the authors appropriately noted the
      steps needed to generalize these results to clinical practice, news reports already have led
      a number of TS patients to contact them asking for treatment. The Nottingham group has
      referred such inquiries from the U.S. to me as leader of our Wash.U. Tourette Association of
      America (TAA) Center of Excellence.

      The hypotheses of this project are that the tic benefits reported by the Nottingham
      investigators are replicable, that they are specific to rhythmic stimulation, which alone
      entrained cortical activity, rather than to a placebo effect, and that they endure past the
      end of stimulation.

      This project (a) will replicate the Nottingham findings using identical methods, and (b) will
      test rhythmic MNS against a placebo treatment (arrhythmic MNS at the same mean frequency). It
      also will gather additional preliminary data needed for a future R01 application, including
      response and tolerability with longer (5-minute) stimulation blocks, and the duration of
      benefit after the end of a stimulation block.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Change in tic frequency from when MNS is turned off

Secondary Outcome

 Change in tic severity after MNS ends

Condition

Tourette Syndrome

Intervention

Rhythmic median nerve stimulation

Study Arms / Comparison Groups

 Experimental: rhythmic MNS, then arrhythmic MNS
Description:  Participants will complete two stimulation sessions, at least a week apart. The first session involves rhythmic MNS and the second uses arrhythmic MNS.

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

32

Start Date

July 15, 2021

Completion Date

February 28, 2022

Primary Completion Date

February 28, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Age 15-64 inclusive at initial screening visit

          -  Informed consent by adult subject; assent by child and informed consent by guardian

          -  Current Tourette's Disorder or Persistent (Chronic) Tic Disorder according to the
             criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition:
             DSM-5

          -  At least 1 tic per minute (average) during the first 5-min. baseline video session on
             the first visit (as scored during the session by the investigator)

        Exclusion Criteria:

          -  Unable to complete study procedures for any reason

          -  Has an implanted device that could be affected by electrical current

          -  Pregnancy known to participant or (for children) to the parent

          -  Known or suspected primary genetic syndrome (e.g. Down syndrome, Fragile X)

          -  Intellectual disability (known, or likely from history and examination)

          -  Head trauma with loss of consciousness for more than 5 minutes

          -  Significant neurologic disease, not counting TS (exceptions include febrile seizures
             or uncomplicated migraine)

          -  Severe or unstable systemic illness

          -  Factors (such as exaggerated signs) that in the judgment of the principal investigator
             make the video recording or YGTSS an inaccurate assessment of tic severity

          -  Judged by investigator to be unlikely to complete study procedures or to return for
             later visits

          -  Change in somatic or psychotherapeutic treatment in the 2 weeks preceding the first
             stimulation visit

          -  Planned change in somatic or psychotherapeutic treatment between the 2 stimulation
             visits
      

Gender

All

Ages

15 Years - 64 Years

Accepts Healthy Volunteers

No

Contacts

Kevin J Black, MD, 314-362-2083, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04731714

Organization ID

202011092

Secondary IDs

UL1TR002345

Responsible Party

Principal Investigator

Study Sponsor

Washington University School of Medicine

Collaborators

 National Center for Advancing Translational Science (NCATS)

Study Sponsor

Kevin J Black, MD, Principal Investigator, Washington University Medical School


Verification Date

July 2021