Abstract

Background: This study evaluated a novel treatment approach using the concept of cranial facial manipulation with an oral appliance, the TicTocStop Tic Guard (TTSTG), also known as the Tic Guard, to determine its safety and efficacy in the treatment of Tourette syndrome (TS) and chronic tic disorders (CTDs). Methods: A two-center study was undertaken at the University of Tennessee Health Science Center and a facility on Long Island, New York. A total of 77 subjects enrolled between the centers upon referral from local neurologists and via Internet enrollment; 67 subjects started the study, and 58 completed the study. A licensed Cognitive Behavioral Intervention for Tics (CBIT) determined the subjects’ Yale Total Tic Severity Score (YTTSS) for tics at enrollment, after 1-week sham appliance, after 1-week Tic Guard, and after 10-weeks Tic Guard. Results: The results showed statistically significant improvement in the YTTSS with both the sham appliance and the Tic Guard with more robust improvement with the Tic Guard. The sham appliance resulted in a 25% overall reduction in tic severity, while the Tic Guard resulted in a 39% overall reduction in tic severity. There were no serious adverse events reported with either device. Conclusions: This study demonstrated significant reduction in YTTSS using the Tic Guard with no reported serious adverse events. As a result, this device could be considered for inclusion in treatment modalities offered to patients with TS/CTD.