Extinction Learning in Adults With Tourette Syndrome

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04498364
Collaborator
(none)
50
1
1
36.4
1.4

Study Details

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 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
  • Behavioral: Habit Reversal Training
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 18, 2020
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 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 8 hours of treatment.

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

Outcome Measures

Primary Outcome Measures

  1. Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS) [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) [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

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Johns Hopkins University School of Medicine Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04498364
Other Study ID Numbers:
  • IRB00256962
First Posted:
Aug 4, 2020
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2021