Trial Outcomes & Findings for Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation (NCT NCT04243798)
NCT ID: NCT04243798
Last Updated: 2026-03-30
Results Overview
Assessment of functional connectivity of sgACC to the DMN using magnetic resonance imaging.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 3), Visit 6 (Day 4), Visit 7 (Day 5) and Immediate Post Treatment Follow Up (Visit 8 and Day 6)
Results posted on
2026-03-30
Participant Flow
Participant milestones
| Measure |
Active TBS-DLPFC
The active group will receive theta-burst TMS stimulation.
Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro x100 TMS system (MagVenture, Denmark).
|
Sham TBS-DLPFC
The sham group will receive sham theta-burst TMS stimulation.
Sham TBS-DLPFC: The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active TBS-DLPFC
The active group will receive theta-burst TMS stimulation.
Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro x100 TMS system (MagVenture, Denmark).
|
Sham TBS-DLPFC
The sham group will receive sham theta-burst TMS stimulation.
Sham TBS-DLPFC: The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation
Baseline characteristics by cohort
| Measure |
Active TBS-DLPFC
n=24 Participants
The active group will receive theta-burst TMS stimulation.
Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro x100 TMS system (MagVenture, Denmark).
|
Sham TBS-DLPFC
n=24 Participants
The sham group will receive sham theta-burst TMS stimulation.
Sham TBS-DLPFC: The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=4 Participants
|
24 Participants
n=28 Participants
|
48 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
47.3 years
STANDARD_DEVIATION 12.1 • n=28 Participants
|
46.05 years
STANDARD_DEVIATION 16.96 • n=10 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=4 Participants
|
9 Participants
n=28 Participants
|
23 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=4 Participants
|
15 Participants
n=28 Participants
|
25 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=4 Participants
|
20 Participants
n=28 Participants
|
43 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants
|
6 Participants
n=28 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=4 Participants
|
17 Participants
n=28 Participants
|
39 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=4 Participants
|
24 Participants
n=28 Participants
|
48 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 3), Visit 6 (Day 4), Visit 7 (Day 5) and Immediate Post Treatment Follow Up (Visit 8 and Day 6)Assessment of functional connectivity of sgACC to the DMN using magnetic resonance imaging.
Outcome measures
| Measure |
Active TBS-DLPFC
n=19 Participants
The active group will receive theta-burst TMS stimulation.
Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro x100 TMS system (MagVenture, Denmark).
|
Sham TBS-DLPFC
n=20 Participants
The sham group will receive sham theta-burst TMS stimulation.
Sham TBS-DLPFC: The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
|
|---|---|---|
|
Change in Resting State Functional Connectivity of the Subgenual Anterior Cingulate Cortex (sgACC) and the Default Mode Network (DMN).
Visit 3 (Day 1)
|
0.0382 Spearman Correlation Coefficient
Standard Deviation 0.0387
|
0.0241 Spearman Correlation Coefficient
Standard Deviation 0.0281
|
|
Change in Resting State Functional Connectivity of the Subgenual Anterior Cingulate Cortex (sgACC) and the Default Mode Network (DMN).
Visit 4 (Day 2)
|
0.0300 Spearman Correlation Coefficient
Standard Deviation 0.0374
|
0.0196 Spearman Correlation Coefficient
Standard Deviation 0.0391
|
|
Change in Resting State Functional Connectivity of the Subgenual Anterior Cingulate Cortex (sgACC) and the Default Mode Network (DMN).
Visit 5 (Day 3)
|
0.0248 Spearman Correlation Coefficient
Standard Deviation 0.0296
|
0.0347 Spearman Correlation Coefficient
Standard Deviation 0.0303
|
|
Change in Resting State Functional Connectivity of the Subgenual Anterior Cingulate Cortex (sgACC) and the Default Mode Network (DMN).
Visit 6 (Day 4)
|
0.0252 Spearman Correlation Coefficient
Standard Deviation 0.0366
|
0.0210 Spearman Correlation Coefficient
Standard Deviation 0.0322
|
|
Change in Resting State Functional Connectivity of the Subgenual Anterior Cingulate Cortex (sgACC) and the Default Mode Network (DMN).
Visit 7 (Day 5)
|
0.0239 Spearman Correlation Coefficient
Standard Deviation 0.0336
|
0.0205 Spearman Correlation Coefficient
Standard Deviation 0.0380
|
|
Change in Resting State Functional Connectivity of the Subgenual Anterior Cingulate Cortex (sgACC) and the Default Mode Network (DMN).
Visit 8 (Day 6)
|
0.0251 Spearman Correlation Coefficient
Standard Deviation 0.0343
|
0.0316 Spearman Correlation Coefficient
Standard Deviation 0.0339
|
SECONDARY outcome
Timeframe: Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 3), Visit 6 (Day 4), Visit 7 (Day 5) and Immediate Post Treatment Follow Up (Visit 8/Day 6))Assessment of functional connectivity of sgACC to the DMN using magnetic resonance imaging.
Outcome measures
| Measure |
Active TBS-DLPFC
n=18 Participants
The active group will receive theta-burst TMS stimulation.
Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro x100 TMS system (MagVenture, Denmark).
|
Sham TBS-DLPFC
n=17 Participants
The sham group will receive sham theta-burst TMS stimulation.
Sham TBS-DLPFC: The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
|
|---|---|---|
|
Relationship Between Clinical Improvement and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 3
|
0.0379 Spearman Correlation Coefficient
Standard Deviation 0.0386
|
0.0233 Spearman Correlation Coefficient
Standard Deviation 0.0282
|
|
Relationship Between Clinical Improvement and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 4
|
0.0289 Spearman Correlation Coefficient
Standard Deviation 0.0382
|
0.0165 Spearman Correlation Coefficient
Standard Deviation 0.0399
|
|
Relationship Between Clinical Improvement and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 5
|
0.0231 Spearman Correlation Coefficient
Standard Deviation 0.0296
|
0.0368 Spearman Correlation Coefficient
Standard Deviation 0.0281
|
|
Relationship Between Clinical Improvement and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 6
|
0.0224 Spearman Correlation Coefficient
Standard Deviation 0.0358
|
0.0247 Spearman Correlation Coefficient
Standard Deviation 0.0311
|
|
Relationship Between Clinical Improvement and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 7
|
0.0231 Spearman Correlation Coefficient
Standard Deviation 0.0341
|
0.0210 Spearman Correlation Coefficient
Standard Deviation 0.0408
|
|
Relationship Between Clinical Improvement and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 8
|
0.024 Spearman Correlation Coefficient
Standard Deviation 0.0350
|
0.0326 Spearman Correlation Coefficient
Standard Deviation 0.0349
|
SECONDARY outcome
Timeframe: Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 3), Visit 6 (Day 4), Visit 7 (Day 5) and Immediate Post Treatment Follow Up (Visit 8/Day 6))Assessment of functional connectivity of sgACC to the DMN using magnetic resonance imaging.
Outcome measures
| Measure |
Active TBS-DLPFC
n=19 Participants
The active group will receive theta-burst TMS stimulation.
Active TBS-DLPFC: Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro x100 TMS system (MagVenture, Denmark).
|
Sham TBS-DLPFC
n=20 Participants
The sham group will receive sham theta-burst TMS stimulation.
Sham TBS-DLPFC: The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
|
|---|---|---|
|
Relationship Between Acute Mood State and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 8
|
0.0251 Spearman Correlation Coefficient
Standard Deviation 0.0343
|
0.0316 Spearman Correlation Coefficient
Standard Deviation 0.0340
|
|
Relationship Between Acute Mood State and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 3
|
0.0382 Spearman Correlation Coefficient
Standard Deviation 0.0387
|
0.0241 Spearman Correlation Coefficient
Standard Deviation 0.0281
|
|
Relationship Between Acute Mood State and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 4
|
0.0300 Spearman Correlation Coefficient
Standard Deviation 0.0374
|
0.0196 Spearman Correlation Coefficient
Standard Deviation 0.0391
|
|
Relationship Between Acute Mood State and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 5
|
0.0248 Spearman Correlation Coefficient
Standard Deviation 0.0296
|
0.0348 Spearman Correlation Coefficient
Standard Deviation 0.0303
|
|
Relationship Between Acute Mood State and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 6
|
0.0252 Spearman Correlation Coefficient
Standard Deviation 0.0366
|
0.0210 Spearman Correlation Coefficient
Standard Deviation 0.0322
|
|
Relationship Between Acute Mood State and Resting State Functional Connectivity Between the sgACC and DMN in Active vs. Sham Participants.
Visit 7
|
0.0239 Spearman Correlation Coefficient
Standard Deviation 0.0336
|
0.0205 Spearman Correlation Coefficient
Standard Deviation 0.0380
|
Adverse Events
Active TBS-DLPFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TBS-DLPFC
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place