Trial Outcomes & Findings for Probing the Dorsolateral Prefrontal Cortex and Central Executive Network for Improving Neuromodulation in Depression (NCT NCT05224063)
NCT ID: NCT05224063
Last Updated: 2026-07-15
Results Overview
TMS-evoked EEG responses were measured before and after intermittent theta burst stimulation (iTBS) using single-pulse TMS probes applied to prefrontal and parietal regions. The primary measure was the change in early TMS-evoked potentials (TEPs), defined as the peak-to-peak amplitude within approximately 20-50 ms following the TMS pulse. Changes in electrophysiological responses were assessed across timepoints (pre-intervention, early post-intervention, and late post-intervention) and compared between active and sham stimulation conditions to characterize modulation of frontoparietal network excitability.
COMPLETED
NA
50 participants
Pre-intervention and up to 20 minutes post-intervention
2026-07-15
Participant Flow
Participant milestones
| Measure |
Neuronavigated rTMS, Then Sham rTMS
Participants receive neuronavigated rTMS based on participants' own MRI images to target the dlPFC, followed by sham rTMS (near the dlPFC to mimic the sensory experience of active stimulation).
|
Sham rTMS, Neuronavigated rTMS
Participants receive sham rTMS (near the dlPFC to mimic the sensory experience of active stimulation), followed by neuronavigated rTMS based on participants' own MRI images to target the dlPFC.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
|
Overall Study
COMPLETED
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Probing the Dorsolateral Prefrontal Cortex and Central Executive Network for Improving Neuromodulation in Depression
Baseline characteristics by cohort
| Measure |
Neuronavigated rTMS, Then Sham RTMS
n=27 Participants
Participants receive neuronavigated rTMS based on participants' own MRI images to target the dlPFC, followed by sham rTMS (near the dlPFC to mimic the sensory experience of active stimulation).
|
Sham rTMS, Then Neuronavigated rTMS
n=23 Participants
Participants receive sham rTMS (near the dlPFC to mimic the sensory experience of active stimulation), followed by neuronavigated rTMS based on participants' own MRI images to target the dlPFC.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
50 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
50 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention and up to 20 minutes post-interventionPopulation: This outcome was analyzed in a within-subject crossover sample. Values are duplicated across arms because the same participants received both active and sham stimulation conditions. The number analyzed reflects participants with evaluable EEG data for this outcome.
TMS-evoked EEG responses were measured before and after intermittent theta burst stimulation (iTBS) using single-pulse TMS probes applied to prefrontal and parietal regions. The primary measure was the change in early TMS-evoked potentials (TEPs), defined as the peak-to-peak amplitude within approximately 20-50 ms following the TMS pulse. Changes in electrophysiological responses were assessed across timepoints (pre-intervention, early post-intervention, and late post-intervention) and compared between active and sham stimulation conditions to characterize modulation of frontoparietal network excitability.
Outcome measures
| Measure |
Neuronavigated rTMS
n=28 Participants
Participants receive neuronavigated rTMS based on participants' own MRI images to target the dlPFC.
|
Sham rTMS
n=28 Participants
Participants receive sham rTMS (near the dlPFC to mimic the sensory experience of active stimulation).
|
|---|---|---|
|
Change in TMS-evoked EEG Responses Following Intermittent Theta Burst Stimulation (iTBS)
Pre-intervention (Baseline)
|
4.28 dBμV
Standard Error 0.58
|
3.95 dBμV
Standard Error 0.48
|
|
Change in TMS-evoked EEG Responses Following Intermittent Theta Burst Stimulation (iTBS)
Post-intervention (up to 20 minutes post-intervention)
|
3.92 dBμV
Standard Error 0.53
|
4.28 dBμV
Standard Error 0.64
|
Adverse Events
Neuronavigated rTMS
Sham rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neuronavigated rTMS
n=50 participants at risk
Participants receive neuronavigated rTMS based on participants' own MRI images to target the dlPFC.
|
Sham rTMS
n=50 participants at risk
Participants receive sham rTMS (near the dlPFC to mimic the sensory experience of active stimulation).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck Stiffness
|
2.0%
1/50 • 1 day
Expected adverse events from TMS-EEG include mild headache, seizure, nausea, migraine, local pain, swelling, or bruising, fatigue, and discomfort.
|
2.0%
1/50 • 1 day
Expected adverse events from TMS-EEG include mild headache, seizure, nausea, migraine, local pain, swelling, or bruising, fatigue, and discomfort.
|
|
Nervous system disorders
Headache
|
6.0%
3/50 • 1 day
Expected adverse events from TMS-EEG include mild headache, seizure, nausea, migraine, local pain, swelling, or bruising, fatigue, and discomfort.
|
6.0%
3/50 • 1 day
Expected adverse events from TMS-EEG include mild headache, seizure, nausea, migraine, local pain, swelling, or bruising, fatigue, and discomfort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place