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

Primary Purpose

Tourette Syndrome, Chronic Tic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Oral Orthotic Treatment
Placebo Oral Orthotic Treatment
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette's, Tic Disorder, Dental Appliance, Oral Orthotic, Mouthguard

Eligibility Criteria

7 Years - 25 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Oral Orthotic Treatment

Placebo Oral Orthotic Treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Number, Frequency, and Intensity of Motor and Vocal Tics as Measured by the Clinical Global Impressions Scale - Severity
To assess global severity of tics and change in the clinical condition over time, the Clinical Global Impressions Scale - Severity (CGI-S) was utilized. The Severity of Illness has a low score of 0 and high score is 7. The low score of 0 represents that the subject was not assessed and the high score of 7 represents among the most extremely ill subjects.

Full Information

First Posted
February 18, 2014
Last Updated
April 29, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
The Hindin Center
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1. Study Identification

Unique Protocol Identification Number
NCT02067819
Brief Title
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
Official Title
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
The Hindin Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Chronic Tic Disorder
Keywords
Tourette's, Tic Disorder, Dental Appliance, Oral Orthotic, Mouthguard

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Oral Orthotic Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Oral Orthotic Treatment
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Active Oral Orthotic Treatment
Other Intervention Name(s)
Occlusal Splint, Oral Orthotic, Dental Orthotic, Dental Appliance
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Placebo Oral Orthotic Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Global Severity of Tics and Clinical Condition as Measured by YGTSS
Description
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.
Time Frame
Baseline Visit, Week 2 Visit
Secondary Outcome Measure Information:
Title
Change in Number, Frequency, and Intensity of Motor and Vocal Tics as Measured by the Clinical Global Impressions Scale - Severity
Description
To assess global severity of tics and change in the clinical condition over time, the Clinical Global Impressions Scale - Severity (CGI-S) was utilized. The Severity of Illness has a low score of 0 and high score is 7. The low score of 0 represents that the subject was not assessed and the high score of 7 represents among the most extremely ill subjects.
Time Frame
Baseline Visit, Week 2 Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Bennett, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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