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 YGTSS
Secondary Outcome
Change in Number, Frequency, and Intensity of Motor and Vocal Tics as Measured by the Clinical Global Impressions Scale - Severity
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
21
Start Date
March 2014
Completion Date
May 2021
Primary Completion Date
May 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
April 2022