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Extinction Learning in Youth With Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT03765463
Recruitment Status : Active, not recruiting
First Posted : December 5, 2018
Last Update Posted : February 16, 2023
Information provided by (Responsible Party):
Johns Hopkins University

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 have not been directly evaluated in youth with Tourette syndrome (TS). This study examines extinction learning and extinction recall in youth 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.

Condition or disease Intervention/treatment Phase
Tourette Syndrome in Children Tourette Syndrome in Adolescence Habit Reversal Training Tic Behavioral: Habit Reversal Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extinction Learning in Youth With Tourette Syndrome
Actual Study Start Date : February 28, 2019
Actual Primary Completion Date : February 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

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 4 two-hour sessions in an intensive format.
Behavioral: Habit Reversal Training
4 sessions of habit reversal training

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Youth with TS will be eligible for participation if they meet the following inclusion criteria:

  • age 8-17 years (inclusive)
  • 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 for youth with TS:

  • An inability to complete rating scales
  • Attend study visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765463

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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Joseph F McGuire, PhD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03765463    
Other Study ID Numbers: IRB00195059
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Extinction learning
Behavior Therapy
Tourette's Disorder
Habit Reversal Training
Comprehensive Behavioral Intervention for Tics
Additional relevant MeSH terms:
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Tourette Syndrome
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders