Brain-Behavior Interactions in Tic Suppression

NCT02205918 | Completed DMC

• 1 other identifier: PSYCH-2017-25550
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Tic frequency

  Tics will be observed and counted

  Day 3

Secondary Outcomes (1)

• Urge to tic

  Day 3

Study Arms (2)

Sham TMS

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

Other: Sham TMS

Active TMS

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

Other: Active TMS

Interventions

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.

Active 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.

Sham TMS

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Christine Conelea, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 1, 2014
• Study Start: July 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)