Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Tic Disorder Tourette Syndrome

Keywords

Tourette'sTic DisorderDental ApplianceOral OrthoticMouthguard

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 TreatmentDevice

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

Active Oral Orthotic Treatment

Placebo Oral Orthotic TreatmentDevice

Eligibility Criteria

Age7 Years - 25 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

The Hindin Center
Othercollaborator
Weill Medical College of Cornell University
Otherlead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

MeSH Terms

Conditions

Tourette SyndromeTic Disorders

Interventions

Occlusal SplintsOrthotic Devices

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental Disorders

Results Point of Contact

Title: Shannon Bennett, PhD
Organization: Weill Cornell Medicine

Study Officials

Shannon Bennett, PhD
Weill Medical College of Cornell University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

21 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Active Oral Orthotic Treatment

Placebo Oral Orthotic Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Active Oral Orthotic Treatment

Placebo Oral Orthotic Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations