- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04498364
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
Status
Completed
Conditions
Intervention / Treatment
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
- Name: Nicholas Myers
- Phone Number: 4432877157
- Email: coach@jhmi.edu
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Medicine
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-
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Syndrome
- Tourette Syndrome
- Tic Disorders
Other Study ID Numbers
- IRB00256962
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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