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CompletedNCT04498364Updated Oct 23, 2023

Extinction Learning in Adults With Tourette Syndrome

An interventional study of Habit Reversal Training in Tourette Syndrome, Habit Reversal Training and Tic Disorders, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tourette Syndrome
  • Habit Reversal Training
  • Tic Disorders
  • Tics
  • Comprehensive Behavioral Intervention for Tics

Keywords

  • Extinction Learning
  • Comprehensive Behavioral Intervention for Tics
  • Behavior Therapy
  • Habit Reversal Training
  • Tourette's Disorder
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In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's enrollment of 10 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralHabit Reversal Training

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

06

What researchers measure

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.

    Time frame: Within 1 week after completion of HRT

Secondary outcomes

  1. 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.

    Time frame: Within 1 week after completion of HRT

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Study locations

1 site
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21205, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Sep 2023, 36 months.

Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's 36 months is close to that.

Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2020
First posted
Aug 4, 2020
StartActual
Sep 18, 2020
Primary completionActual
Sep 22, 2023
CompletionActual
Oct 17, 2023
Last update
Oct 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04498364
Responsible party
Sponsor
First posted
Aug 4, 2020
Start date
Sep 18, 2020
Primary completion
Sep 22, 2023
Completion
Oct 17, 2023
Last update
Oct 23, 2023

Study contacts

Joseph F McGuire, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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