N/A
N=21
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
Tourette Syndrome · Chronic Tic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02067819 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Change in Global Severity of Tics and Clinical Condition as Measured by YGTSS — 20.19; 25.82 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Oral Orthotic Treatment (Device); Placebo Oral Orthotic Treatment (Device)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Severity of Tics and Clinical Condition as Measured by YGTSS |
20.19; 25.82 | — |
| SECONDARY Change in Number, Frequency, and Intensity of Motor and Vocal Tics as Measured by the Clinical Global Impressions Scale - Severity |
4.57; 5.27 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02067819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.