NCT03628703

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
1 month until next milestone

Results Posted

Study results publicly available

April 18, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

4.2 years

First QC Date

August 10, 2018

Results QC Date

March 20, 2024

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stop Signal Reaction Time (SSRT)

    SSRT measured from modified Slater-Hammel stop signal task performance. The SSRT is calculated by subtracting the average stop signal delay (msec) from the average go-trial reaction time. The SSRT is a measure of inhibitory behavior. The lower the SSRT value means a person is better at inhibitory control. The higher the SSRT value means a person is worse at inhibitory control.

    30 minutes after Repetitive Transcranial Magnetic Stimulation (as it takes about 30 minutes to complete the modified Slater-Hammel stop signal task)

Study Arms (1)

Repetitive TMS

EXPERIMENTAL

Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation

Device: Repetitive TMS

Interventions

Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area

Repetitive TMS

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Tourette Syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Steve W. Wu, M.D.
Organization
Cincinnati Children's Hospital Medical Center

Study Officials

  • Steve W. Wu, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 14, 2018

Study Start

April 22, 2019

Primary Completion

June 30, 2023

Study Completion

March 15, 2024

Last Updated

April 18, 2024

Results First Posted

April 18, 2024

Record last verified: 2024-04

Locations