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Completed

NCT Number: NCT02205918

Brain-Behavior Interactions in Tic Suppression

The purpose of this study is to examine how the brain and environment interact to influence children's ability to suppress tics using a medical technology called Transcranial Magnetic Stimulation (TMS).

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Key information

About this study

Objectives: This study will recruit youth with chronic tics. Chronic tics are the most common movement disorder in children. The goal of the study is to learn how the brain and environment influence children's ability to suppress tics. Specifically, we want to learn how tics are influenced by a certain part of the brain called the supplementary motor area (SMA). This part of the brain is thought to be more active in people with tics. This will be the first study to look at the relationship between SMA, tic suppression, and urges to tic.

Research Procedures: The study will take place over the course of three days within a week (about 5 hours total). The study will examine the relationship between the SMA and tic suppression using a non-invasive medical technology called Transcranial Magnetic Stimulation (TMS). Participants will have a diagnostic interview, MRI brain scan (used to find the location of the SMA), and TMS. Participants will be asked to try to suppress tics before and after TMS. The information that will be collected from participation includes information about tic symptoms, emotional and behavioral functioning, and brain activity (from MRI brain images and TMS results).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of motor and/or vocal tics for at least one year
  • English fluency

Exclusion criteria

  • Participants with medical conditions that are contraindicated for TMS (history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or girls of childbearing age not using effective contraception, or any other serious medical conditions
  • Left-handedness
  • Previous diagnosis of psychosis, autism spectrum disorder, mental retardation, or cognitive disability
  • Inability to undergo MRI
  • Substance abuse or dependence within the past year
  • History of ≥3 sessions of Habit Reversal Therapy or other treatment primarily comprised of tic suppression strategies
  • Current suicidal intent
  • Current neuroleptic medications, as these medications are known to lower seizure threshold

Treatment and study plan

Active TMS

Other

There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive 1hz "active" TMS. Tics and urges will be monitored immediately before and after TMS.

Sham TMS

Other

There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive inactive ("sham") TMS. Tics and urges will be monitored immediately before and after TMS.

Primary outcomes

  1. Tic frequency

    Time frame: Day 3

    Tics will be observed and counted

Secondary outcomes

  1. Urge to tic

    Time frame: Day 3

    The participant will be asked to give subjective ratings of premonitory urge intensity

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Integrative Examination of Neurobehavioral Mechanisms in Tic Suppression

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2014
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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