Trial Outcomes & Findings for Response Inhibition in Tourette Syndrome (NCT NCT03628703)

NCT ID: NCT03628703

Last Updated: 2024-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

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

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure
Repetitive TMS
Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation Repetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Response Inhibition in Tourette Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Repetitive TMS
n=10 Participants
Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation Repetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area
Age, Continuous
14.9 years
STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
10 participants
n=5 Participants
Yale Global Tic Severity Scale
19.3 units on a scale
STANDARD_DEVIATION 10.1 • n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Repetitive TMS
n=10 Participants
Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation Repetitive TMS: Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area
Stop Signal Reaction Time (SSRT)
Before Repetitive TMS
249 milliseconds
Standard Deviation 28.0
Stop Signal Reaction Time (SSRT)
After Repetitive TMS
245 milliseconds
Standard Deviation 11.2

Adverse Events

Repetitive TMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steve W. Wu, M.D.

Cincinnati Children's Hospital Medical Center

Phone: 513-636-4222

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place