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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tourette Syndrome, Chronic Tic Disorder

Intervention / Treatment
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* Device: Active Oral Orthotic Treatment
* Device: Placebo Oral Orthotic Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Oral Orthotic Treatment<br>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. | Device: Active Oral Orthotic Treatment<br>* 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.<br>* Other names: Dental Appliance;|
| Placebo Comparator: Placebo Oral Orthotic Treatment<br>Control participants will receive an identical sham splint to the active condition, but not adjusted to the recommended height for the given participant. Participants will be asked to wear the orthotic 24/7 for the duration of the study. | Device: Placebo Oral Orthotic Treatment<br>* After two weeks, this 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Global Severity of Tics and Clinical Condition as Measured by YGTSS | The primary clinical outcome measures included the Yale Global Tic Severity Scale (YGTSS). The YGTSS is a semi structured interview designed to elicit information regarding the character & anatomical distribution of tics observed during the course of 1 week interval, prior to clinical assessment. Following completion of the interview & construction of a tic inventory, clinicians rate severity of motor and photic tics along with 5 separate dimensions (frequency, intensity, number, complexity, interference). The YGTSS is comprised of a list of motor and vocal tics & the participant endorses which tics are currently present. Motor and vocal tics are then separately rated for Number, Frequency, Intensity, Complexity, Interference & Impairment, each on a 6 point likert scale ranging from 0 (none) to 5 (Severe).This results in a range of 0-25 for motor tics & 0-25 for vocal tics, for a total score range of 0-50. A score of 0 indicating a lack of tics & 50 represent the most severe tics. | Baseline Visit, Week 2 Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number, Frequency, and Intensity of Motor and Vocal Tics as Measured by the Clinical Global Impressions Scale - Severity | To assess global severity of tics and change in the clinical condition over time, the Clinical Global Impressions Scale - Severity (CGI-S) was utilized. The Severity of Illness has a low score of 0 and high score is 7. The low score of 0 represents that the subject was not assessed and the high score of 7 represents among the most extremely ill subjects. | Baseline Visit, Week 2 Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourette's, Tic Disorder, Dental Appliance, Oral Orthotic, Mouthguard