Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tou… (NCT02067819) | Clinical Trial Compass
CompletedNot Applicable
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
United States21 participantsStarted 2014-03
Plain-language 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).
Who can participate
Age range7 Years – 25 Years
SexALL
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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 as…
What they're measuring
1
Change in Global Severity of Tics and Clinical Condition as Measured by YGTSS
Timeframe: Baseline Visit, Week 2 Visit
Trial details
NCT IDNCT02067819
SponsorWeill Medical College of Cornell University