Brain-Behavior Interactions in Tic Suppression

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02205918
Collaborator
(none)
30
1
26
1.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Active TMS
  • Other: Sham 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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Integrative Examination of Neurobehavioral Mechanisms in Tic Suppression
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Tic frequency [Day 3]

    Tics will be observed and counted

Secondary Outcome Measures

  1. Urge to tic [Day 3]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02205918
Other Study ID Numbers:
  • PSYCH-2017-25550
First Posted:
Aug 1, 2014
Last Update Posted:
Jul 17, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2020