Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome

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Brief Title

Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome

Official Title

Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome

Brief Summary

      The purpose of this study is to assess the feasibility of a trial on an oral orthotic for
      reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic
      Disorder (CTD).
    

Detailed Description

      The study is a 2 group, 2 week randomized controlled feasibility trial of an active vs sham
      oral orthotic to reduce tic severity in children and adolescents ages 7-25 years. Responders
      to acute phase treatment will be followed for 10 additional week (12 weeks total) to assess
      intervention durability, safety and acceptability. Non-responders to the sham orthotic will
      be provided active treatment at the end of the 2 week acute phase. We aim to assess and
      enroll 24 participants; twelve participants will receive an orthotic adjusted to the
      appropriate therapeutic height, and twelve participants will receive an identical sham
      orthotic, but not adjusted to the recommended height for the given participant.
    


Study Type

Interventional


Primary Outcome

Change in global severity of tics and clinical condition as measured by CGI

Secondary Outcome

 Change in parent-reported number, frequency and intensity of child's motor and vocal tics as measured by PTQ

Condition

Tourette Syndrome

Intervention

Active Oral Orthotic Treatment

Study Arms / Comparison Groups

 Active Oral Orthotic Treatment
Description:  Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.

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

40

Start Date

March 2014

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Age 7-25 inclusive.

          -  Presence of motor and/or vocal tics for at least 12 months.

          -  Tics are of at least moderate clinical severity as evidenced by a Yale Global Tic
             Severity score of 14 or higher for motor or vocal tics only and 22 or higher for
             Tourette syndrome and present during the baseline assessment.

          -  IQ estimate of 70 or higher

          -  Comorbid disorder (e.g., ADHD, OCD, ODD) will be allowed provided that the tic
             symptoms are of primary concern to parents and comorbid symptoms are not of sufficient
             severity to require immediate treatment other than that provided by the current study.

          -  Pre-existing stable medication (see protocol for details), tic or otherwise, will also
             be allowed provided the family agrees to refrain from med changes over the course of
             the acute phase of the study

          -  Sufficient command of the English language to participate in informed consent and
             assessment procedures.

          -  Agree for videotaping of study procedures

          -  Clearance by treating dentist: Certification of good dental health provided by the
             subjects current dentist prior to enrollment in the study

        Exclusion Criteria:

          -  Major psychiatric disorder at screening that would preclude full participation in
             study procedures including psychosis, mania, depression, untreated combined type ADHD,
             autism and pervasive developmental disorders.

          -  Medication changes are planned during the acute and follow-up phase of treatment.

          -  Other dental health problems that might interfere with the assessment, installation,
             or wearing of orthotic device.

          -  Does not consent to being videotaped
      

Gender

All

Ages

7 Years - 25 Years

Accepts Healthy Volunteers

No

Contacts

Shannon Bennett, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02067819

Organization ID

1208012905


Responsible Party

Sponsor

Study Sponsor

Weill Medical College of Cornell University

Collaborators

 The Hindin Center

Study Sponsor

Shannon Bennett, PhD, Principal Investigator, Weill Medical College of Cornell University


Verification Date

February 2021