Brain-Behavior Interactions in Tic Suppression

Integrative Examination of Neurobehavioral Mechanisms 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).

Study Overview

• Status: Completed
• Conditions: Tourette's Syndrome; Chronic Motor Tic Disorder; Chronic Vocal Tic Disorder
• Intervention / Treatment: Other: Sham TMS; Other: Active TMS

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sham TMS; Participants in this group will receive one, 30 minute session of inactive ("sham") TMS.	Other: Sham TMS; 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.
Active TMS; Participants in this group will receive one, 30 minute session of 1hz TMS.	Other: Active TMS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tic frequency	Tics will be observed and counted	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urge to tic	The participant will be asked to give subjective ratings of premonitory urge intensity	Day 3

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Christine Conelea, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 1, 2019

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (ESTIMATE): August 1, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Disease; Tourette Syndrome; Tic Disorders; Tics
• Other Study ID Numbers: PSYCH-2017-25550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO