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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
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.
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.
Weill Cornell Medical College
New York, New York, United States
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.
Time frame: Baseline Visit, Week 2 Visit
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.
Time frame: Baseline Visit, Week 2 Visit
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