Trial Outcomes & Findings for Effects of rTMS on Human Brain Activity Measured With fMRI (NCT NCT03259568)
NCT ID: NCT03259568
Last Updated: 2023-03-29
Results Overview
Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
during each TMS session, up to 3 hours
Results posted on
2023-03-29
Participant Flow
Participant milestones
| Measure |
Active rTMS
Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Active rTMS
Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity.
|
|---|---|
|
Overall Study
Participant performance was low
|
3
|
Baseline Characteristics
Within-subjects design, each subject received four TMS conditions ("arms").
Baseline characteristics by cohort
| Measure |
Active rTMS (Repetitive Transcranial Magnetic Stimulation)
n=27 Participants
Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity.
|
|---|---|
|
Age, Continuous
|
23.7 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants • Within-subjects design, each subject received four TMS conditions ("arms").
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants • Within-subjects design, each subject received four TMS conditions ("arms").
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants • Within-subjects design, all conditions ("arms") were repeated in each of the 27 participants.
|
|
fMRI Activity
20% RMT
|
1.28 BOLD response
STANDARD_DEVIATION 0.14 • n=5 Participants
|
|
fMRI Activity
40% RMT
|
1.28 BOLD response
STANDARD_DEVIATION 0.12 • n=5 Participants
|
|
fMRI Activity
80% RMT
|
1.20 BOLD response
STANDARD_DEVIATION 0.14 • n=5 Participants
|
|
fMRI Activity
120% RMT
|
1.25 BOLD response
STANDARD_DEVIATION 0.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: during each TMS session, up to 3 hoursPopulation: Within-subjects manipulation (same subjects for each condition).
Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)
Outcome measures
| Measure |
Dose-response TMS - Intensity = 20%RMT
n=24 Participants
Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 40%RMT
n=24 Participants
Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 80%RMT
n=24 Participants
Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 120%RMT
n=24 Participants
Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
|---|---|---|---|---|
|
Motion Perception Accuracy
|
63 Percentage of correct responses
Standard Error 4.0
|
62 Percentage of correct responses
Standard Error 4.0
|
58 Percentage of correct responses
Standard Error 4.0
|
61 Percentage of correct responses
Standard Error 3.0
|
PRIMARY outcome
Timeframe: during each TMS session, up to 3 hoursPopulation: Within-subjects manipulation (same subjects for each condition).
Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)
Outcome measures
| Measure |
Dose-response TMS - Intensity = 20%RMT
n=24 Participants
Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 40%RMT
n=24 Participants
Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 80%RMT
n=24 Participants
Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 120%RMT
n=24 Participants
Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
|---|---|---|---|---|
|
Reaction Time
|
814 milliseconds
Standard Error 104
|
784 milliseconds
Standard Error 94
|
762 milliseconds
Standard Error 85
|
810 milliseconds
Standard Error 109
|
PRIMARY outcome
Timeframe: during each TMS session, up to 3 hoursPopulation: Within-subjects manipulation (same subjects for each condition).
Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal
Outcome measures
| Measure |
Dose-response TMS - Intensity = 20%RMT
n=24 Participants
Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 40%RMT
n=24 Participants
Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 80%RMT
n=24 Participants
Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
Dose-response TMS - Intensity = 120%RMT
n=24 Participants
Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
|
|---|---|---|---|---|
|
Activation of Cortical Networks During a Visual Motion Task.
|
0.89 BOLD activity
Standard Deviation 0.06
|
0.87 BOLD activity
Standard Deviation 0.05
|
0.88 BOLD activity
Standard Deviation 0.06
|
0.94 BOLD activity
Standard Deviation 0.04
|
Adverse Events
Dose-response TMS - Intensity = 20%RMT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose-response TMS - Intensity = 40%RMT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose-response TMS - Intensity = 80%RMT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose-response TMS - Intensity = 120%RMT
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
Simon W Davis
Dept of Neurology, Duke University School of Medicine
Phone: 9195991927
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place