NCT04498364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

July 31, 2020

Last Update Submit

October 20, 2023

Conditions

Keywords

Extinction LearningComprehensive Behavioral Intervention for TicsBehavior TherapyHabit Reversal TrainingTourette's Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)

    Within 1 week after completion of HRT

Study Arms (1)

Habit Reversal Training

EXPERIMENTAL

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

Interventions

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

Habit Reversal Training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • An inability to complete rating scales
  • An inability to attend study visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Tourette SyndromeTic DisordersTics

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph F McGuire, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 4, 2020

Study Start

September 18, 2020

Primary Completion

September 22, 2023

Study Completion

October 17, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations