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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Chronic Tic Disorder; Tourette Syndrome

Treatments: Device: Placebo Oral Orthotic Treatment; Device: Active Oral Orthotic Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02067819

1208012905

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 7 to 25 years old

Volunteers: No Healthy Volunteers

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 assessment, installation, or wearing of orthotic device.
• Does not consent to being videotaped

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Active Oral Orthotic Treatment

Experimental group

Description:

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.

Treatment:

Device: Active Oral Orthotic Treatment

Placebo Oral Orthotic Treatment

Placebo Comparator group

Description:

Control participants will receive an identical sham splint to the active condition, but not adjusted to the recommended height for the given participant. Participants will be asked to wear the orthotic 24/7 for the duration of the study.

Treatment:

Device: Placebo Oral Orthotic Treatment