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Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome

Clinical Trial 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).

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02067819
Study type Interventional
Source Weill Medical College of Cornell University
Contact
Status Completed
Phase N/A
Start date March 2014
Completion date May 2021
View Details
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