Extinction Learning in Youth With Tourette Syndrome

Tourette Syndrome in Adolescence Clinical Trial

Official title:

Extinction Learning in Youth With Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765463
• Other study ID #: IRB00195059
• Status: Completed
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: August 2, 2023

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Habit Reversal Training
• Syndrome
• Tic
• Tourette Syndrome
• Tourette Syndrome in Adolescence
• Tourette Syndrome in Children

Intervention

Behavioral:
• Habit Reversal Training
4 sessions of habit reversal training

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 1 week after completion of HRT
Secondary	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.	Within 1 week after completion of HRT