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Response Inhibition in Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT03628703
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief Summary:
Tics are the hallmark symptoms in Tourette Syndrome. Patients with Tourette Syndrome have difficulties controlling unwanted movements. The ability to control the motor system involves the pre-supplementary motor area (pre-SMA) in the brain. In this study, we will use Transcranial Magnetic Stimulation to modulate the pre-SMA and determine effect on the ability to stop an unwanted action in a behavior task (stop signal task).

Condition or disease Intervention/treatment Phase
Tourette Syndrome Device: Repetitive TMS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Using Repetitive Transcranial Magnetic Stimulation to Modulate Response Inhibition in Tourette Syndrome
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Repetitive TMS
Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation
 Device: Repetitive TMS
Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area


Outcome Measures
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Primary Outcome Measures :
  1. Stop Signal Reaction Time (SSRT) [ Time Frame: Immediately after Repetitive Transcranial Magnetic Stimulation ]
    SSRT measured from stop signal task performance


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tourette Syndrome

Exclusion Criteria:

  • Autism spectrum disorder
  • Mood disorder
  • Epilepsy
  • Implanted medical device (e.g. pacemaker, shunt, pumps)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628703


Contacts
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Contact: Hannah Jackson 513-803-2670 hannah.jackson@cchmc.org
Contact: Steve W. Wu, MD 513-636-4222 tics@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Hannah Jackson    513-803-2670    hannah.jackson@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Steve W. Wu, MD Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03628703    
Other Study ID Numbers: CIN001 - TAA2018
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tourette Syndrome
Syndrome
Disease
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders