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

NCT02067819 | Completed Results DMC FDA Device

• 1 other identifier: 1208012905
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Tourette Syndrome; Chronic Tic Disorder

Keywords

Tourette's; Tic Disorder; Dental Appliance; Oral Orthotic; Mouthguard

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline Visit, Week 2 Visit

Secondary Outcomes (1)

• Change in Number, Frequency, and Intensity of Motor and Vocal Tics as Measured by the Clinical Global Impressions Scale - Severity

  Baseline Visit, Week 2 Visit

Study Arms (2)

Active Oral Orthotic Treatment

EXPERIMENTAL

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.

Device: Active Oral Orthotic Treatment

Placebo Oral Orthotic Treatment

PLACEBO COMPARATOR

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.

Device: Placebo Oral Orthotic Treatment

Interventions

Active Oral Orthotic Treatment DEVICE

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.

Also known as: Occlusal Splint, Oral Orthotic, Dental Orthotic, Dental Appliance

Active Oral Orthotic Treatment

Placebo Oral Orthotic Treatment DEVICE

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.

Placebo Oral Orthotic Treatment

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• The Hindin Center: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Occlusal Splints; Orthotic Devices

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Shannon Bennett, PhD
• Organization: Weill Cornell Medicine

smb9017@med.cornell.edu

646-962-2820

Study Officials

• Shannon Bennett, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 24, 2022
• Results First Posted: May 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)