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Response Inhibition in Tourette Syndrome

Primary Purpose

Tourette Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive TMS
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tourette Syndrome

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Tourette Syndrome

Exclusion Criteria:

  • Autism spectrum disorder
  • Mood disorder
  • Epilepsy
  • Implanted medical device (e.g. pacemaker, shunt, pumps)

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repetitive TMS

Arm Description

Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation

Outcomes

Primary Outcome Measures

Stop Signal Reaction Time (SSRT)
SSRT measured from stop signal task performance

Secondary Outcome Measures

Full Information

First Posted
August 10, 2018
Last Updated
July 6, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03628703
Brief Title
Response Inhibition in Tourette Syndrome
Official Title
Using Repetitive Transcranial Magnetic Stimulation to Modulate Response Inhibition in Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repetitive TMS
Arm Type
Experimental
Arm Description
Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Repetitive TMS
Intervention Description
Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area
Primary Outcome Measure Information:
Title
Stop Signal Reaction Time (SSRT)
Description
SSRT measured from stop signal task performance
Time Frame
Immediately after Repetitive Transcranial Magnetic Stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Tourette Syndrome Exclusion Criteria: Autism spectrum disorder Mood disorder Epilepsy Implanted medical device (e.g. pacemaker, shunt, pumps)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Jackson
Phone
513-803-2670
Email
hannah.jackson@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Steve W. Wu, MD
Phone
513-636-4222
Email
tics@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve W. Wu, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Jackson
Phone
513-803-2670
Email
hannah.jackson@cchmc.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Response Inhibition in Tourette Syndrome

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