Trial Outcomes & Findings for TMS Modulation of Insula-related Brain Networks.02 (NCT NCT02919423)
NCT ID: NCT02919423
Last Updated: 2019-02-15
Results Overview
Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.
COMPLETED
NA
36 participants
baseline and 1 week
2019-02-15
Participant Flow
5 subjects were consented but did not meet eligibility criteria and were not randomized to a condition.
Participant milestones
| Measure |
10 Hz TMS
This group received 10 Hz TMS
|
1 Hz TMS
This group received 1 Hz TMS
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
25
|
|
Overall Study
COMPLETED
|
4
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TMS Modulation of Insula-related Brain Networks.02
Baseline characteristics by cohort
| Measure |
10 Hz TMS
n=6 Participants
This group received 10 Hz TMS
|
1 Hz TMS
n=25 Participants
This group received 1 Hz TMS
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 7 • n=99 Participants
|
31 years
STANDARD_DEVIATION 12 • n=107 Participants
|
30 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 weekDifference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.
Outcome measures
| Measure |
10 Hz TMS
n=6 Participants
This group received 10 Hz TMS
|
1 Hz TMS
n=25 Participants
This group received 1 Hz TMS
|
|---|---|---|
|
Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging
|
.25 correlation coefficient
|
.13 correlation coefficient
|
Adverse Events
10 Hz TMS
1 Hz TMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Merideth Addicott, Assistant Professor
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place