Brain-Behavior Interactions in Tic Suppression

NCT ID: NCT02205918

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-09-01

Brief Summary

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).

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).

Conditions

Tourette's Syndrome; Chronic Motor Tic Disorder; Chronic Vocal Tic Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Sham TMS

Participants in this group will receive one, 30 minute session of inactive ("sham") TMS.

Sham TMS

Intervention Type: 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.

Active TMS

Participants in this group will receive one, 30 minute session of 1hz TMS.

Active TMS

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Conelea, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PSYCH-2017-25550

Identifier Type: -

Identifier Source: org_study_id