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Trial Outcomes & Findings for TMS Related Biomarker Assessments (NCT NCT05660018)

NCT ID: NCT05660018

Last Updated: 2026-01-09

Results Overview

The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. Stronger rsFC (i.e., larger positive z score) was related to stronger connection between the two brain regions. The differences of rsFC between active and sham were reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by active TMS.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

2 weeks

Results posted on

2026-01-09

Participant Flow

Participant milestones

Participant milestones
Measure
Active rTMS First and Sham rTMS Second
Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit. active rTMS first, then sham rTMS: Active rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit.
Sham rTMS First and Active rTMS Second
Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit. sham rTMS first, then active rTMS: Sham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit.
Overall Study
STARTED
5
5
Overall Study
COMPLETED
5
5
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TMS Related Biomarker Assessments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active rTMS First and Sham rTMS Second
n=5 Participants
Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit. active rTMS first, then sham rTMS: Active rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit.
Sham rTMS First and Active rTMS Second
n=5 Participants
Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit. sham rTMS first, then active rTMS: Sham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit.
Total
n=10 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=8 Participants
5 Participants
n=7 Participants
10 Participants
n=15 Participants
Age, Categorical
>=65 years
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Age, Continuous
38.8 years
STANDARD_DEVIATION 18.2 • n=8 Participants
39.2 years
STANDARD_DEVIATION 16.2 • n=7 Participants
39.0 years
STANDARD_DEVIATION 16.2 • n=15 Participants
Sex: Female, Male
Female
3 Participants
n=8 Participants
3 Participants
n=7 Participants
6 Participants
n=15 Participants
Sex: Female, Male
Male
2 Participants
n=8 Participants
2 Participants
n=7 Participants
4 Participants
n=15 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=8 Participants
5 Participants
n=7 Participants
10 Participants
n=15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Race (NIH/OMB)
Asian
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=8 Participants
3 Participants
n=7 Participants
7 Participants
n=15 Participants
Race (NIH/OMB)
White
1 Participants
n=8 Participants
2 Participants
n=7 Participants
3 Participants
n=15 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
Region of Enrollment
United States
5 Participants
n=8 Participants
5 Participants
n=7 Participants
10 Participants
n=15 Participants

PRIMARY outcome

Timeframe: 2 weeks

The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. Stronger rsFC (i.e., larger positive z score) was related to stronger connection between the two brain regions. The differences of rsFC between active and sham were reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by active TMS.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
Participants who received active rTMS in either the first or the second visit.
Sham rTMS
n=10 Participants
Participants who received sham rTMS in either the first or second visit.
Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS
0.018 z score of functional connectivity
Standard Error 0.018
0.007 z score of functional connectivity
Standard Error 0.027

PRIMARY outcome

Timeframe: 2 weeks

TMS effect is explored by comparing MMN changes from active and sham rTMS. MMN is measured by subtracting the averaged EEG response to a set of standard stimuli from the averaged response to rarer deviant stimuli, and taking the amplitude of this difference wave in a given time window. The differences of MMN between active and sham were reported. A negative (positive) value of rsFC change suggests the MMN was enhanced (weakened) by active TMS.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
Participants who received active rTMS in either the first or the second visit.
Sham rTMS
n=10 Participants
Participants who received sham rTMS in either the first or second visit.
Change of Mismatch Negativity (MMN) From Electroencephalography (EEG) Signals by Active and Sham rTMS
-0.106 microvolts
Standard Error 0.367
0.044 microvolts
Standard Error 0.217

Adverse Events

Active rTMS

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

Sham rTMS

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

Dr. Xiaoming Du

UTHealth Houston

Phone: 4438829717

Results disclosure agreements

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