CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Active Oral Orthotic Treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02067819
NCT02067819N/ACompleted
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Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome

Weill Medical College of Cornell University·interventional·Posted Feb 20, 2014·Updated May 24, 2022

In Brief

A clinical study evaluating Active Oral Orthotic Treatment and Placebo Oral Orthotic Treatment for Tourette Syndrome and Chronic Tic Disorder. Completed, enrolled 21 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome, Chronic Tic Disorder
CountriesUnited States
CollaboratorsThe Hindin Center

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2014
Enrollment StartMar 1, 2014
Primary CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 12.4 years ago

Interventions

Active Oral Orthotic Treatmentdevice

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.

Placebo Oral Orthotic Treatmentdevice

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.