Extinction Learning in Adults With Tourette Syndrome

October 20, 2023 updated by: Johns Hopkins University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Habit Reversal Training
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics. It will be delivered over 8 hours of treatment.
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)
Time Frame: Within 1 week after completion of HRT
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.
Within 1 week after completion of HRT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)
Time Frame: Within 1 week after completion of HRT
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.
Within 1 week after completion of HRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joseph F McGuire, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

October 17, 2023

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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