Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
Tourette Syndrome, Chronic Tic Disorder
About this trial
This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette's, Tic Disorder, Dental Appliance, Oral Orthotic, Mouthguard
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
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active Oral Orthotic Treatment
Placebo Oral Orthotic Treatment
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.
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.