Clinical trial NCT02067819: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Chronic Tic Disorder
Keywords: Tourette's
Tic Disorder
Dental Appliance
Oral Orthotic
Mouthguard
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: The Hindin Center
First posted: 2014-02-20
Enrollment: 21
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Global Severity of Tics and Clinical Condition as Measured by YGTSS
timeFrame: Baseline Visit, Week 2 Visit
Secondary outcomes:
measure: Change in Number, Frequency, and Intensity of Motor and Vocal Tics as Measured by the Clinical Global Impressions Scale - Severity
timeFrame: Baseline Visit, Week 2 Visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shannon Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References: