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Extinction Learning in Adults With Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT04498364
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Habit Reversal Training Tic Disorders Tics Comprehensive Behavioral Intervention for Tics Behavioral: Habit Reversal Training Not Applicable

Study Design
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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 Adults With Tourette Syndrome
Actual Study Start Date : September 18, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Behavioral: Habit Reversal Training
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT04498364


Contacts
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Contact: Nicholas Myers 4432877157 coach@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Nicholas Myers, M.A    443-287-7157    coach@jhmi.edu   
Principal Investigator: Joseph McGuire, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Joseph F McGuire, PhD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04498364    
Other Study ID Numbers: IRB00256962
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
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
Comprehensive Behavioral Intervention for Tics
Behavior Therapy
Habit Reversal Training
Tourette's Disorder
Additional relevant MeSH terms:
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Tourette Syndrome
Tic Disorders
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders