Extinction Learning in Youth With Tourette Syndrome

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

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 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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

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

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

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

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03765463
• Other Study ID Numbers: IRB00195059
• First Posted: December 5, 2018
• Last Update Posted: February 16, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Tourette Syndrome; Syndrome; Disease; 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