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Extinction Learning in Adults With Tourette Syndrome

Primary Purpose

Tourette Syndrome, Habit Reversal Training, Tic Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Habit Reversal Training
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Extinction Learning, Comprehensive Behavioral Intervention for Tics, Behavior Therapy, Habit Reversal Training, Tourette's Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 18 years old,
  • Have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (>9 for youth with motor or vocal tics only)
  • Have not received more than 4 previous sessions of HRT
  • Be fluent in English
  • Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment.

Exclusion Criteria:

  • An inability to complete rating scales
  • An inability to attend study visits

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Habit Reversal Training

Arm Description

Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics. It will be delivered over 8 hours of treatment.

Outcomes

Primary Outcome Measures

Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)
Patient will nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on the composite two (vocal and motor) 5-point HM/VTS scale ranging from none (0) to severe (4) for the motor as well as vocal tics. The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score.

Secondary Outcome Measures

Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)
The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity. The YGTSS has demonstrated treatment sensitivity to pharmacotherapy and behavioral interventions.

Full Information

First Posted
July 31, 2020
Last Updated
October 20, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04498364
Brief Title
Extinction Learning in Adults With Tourette Syndrome
Official Title
Extinction Learning in Adults With Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
October 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

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

5. Study Description

Brief Summary
Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but are still understudied for individuals with Tourette syndrome (TS). This study examines extinction learning and extinction recall in adults with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Habit Reversal Training, Tic Disorders, Tics, Comprehensive Behavioral Intervention for Tics
Keywords
Extinction Learning, Comprehensive Behavioral Intervention for Tics, Behavior Therapy, Habit Reversal Training, Tourette's Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Habit Reversal Training
Arm Type
Experimental
Arm Description
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics. It will be delivered over 8 hours of treatment.
Intervention Type
Behavioral
Intervention Name(s)
Habit Reversal Training
Intervention Description
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.
Primary Outcome Measure Information:
Title
Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)
Description
Patient will nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on the composite two (vocal and motor) 5-point HM/VTS scale ranging from none (0) to severe (4) for the motor as well as vocal tics. The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score.
Time Frame
Within 1 week after completion of HRT
Secondary Outcome Measure Information:
Title
Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)
Description
The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity. The YGTSS has demonstrated treatment sensitivity to pharmacotherapy and behavioral interventions.
Time Frame
Within 1 week after completion of HRT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 18 years old, Have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (>9 for youth with motor or vocal tics only) Have not received more than 4 previous sessions of HRT Be fluent in English Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment. Exclusion Criteria: An inability to complete rating scales An inability to attend study visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph F McGuire, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Extinction Learning in Adults With Tourette Syndrome

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