Trial Outcomes & Findings for TMS for Anxiety and Trauma-related Disorders (NCT NCT06475040)
NCT ID: NCT06475040
Last Updated: 2026-06-24
Results Overview
The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety symptom severity. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity.
COMPLETED
NA
15 participants
Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
2026-06-24
Participant Flow
Treatment-resistant anxiety patients seeking outpatient care at Shanghai Mental Health Center, the largest psychiatric hospital in Shanghai, China, were recruited. Fifteen participants consented to participate in this study between June 19th, 2024 and April 13th, 2025.
15 participants were initially recruited. 3 participants were excluded from the final analysis: 2 withdrew following the first day of aiTBS due to perceived worsening of nightmares and headaches, and 1 was excluded after abruptly discontinuing a prescribed anxiety medication and initiating a new medication. 12 participants were included in the final analysis.
Participant milestones
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
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|---|---|
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Overall Study
Adverse Event
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2
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Baseline Characteristics
Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
Baseline characteristics by cohort
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
n=12 Participants
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
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|---|---|
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Age, Continuous
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36.7 years
STANDARD_DEVIATION 11.2 • n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Sex: Female, Male
Female
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6 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Sex: Female, Male
Male
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6 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Race (NIH/OMB)
Asian
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12 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Race (NIH/OMB)
Black or African American
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0 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Race (NIH/OMB)
White
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0 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants • Fifteen participants consented to participate. Two withdrew after the first day of aiTBS due to perceived increase in nightmares and headaches. As mentioned, a third participant was removed for abruptly self-discontinuing a prescribed anxiety medication. Results from the final sample (N = 12) are displayed in the paper.
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Region of Enrollment
China
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12 Participants
n=20 Participants
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Beck Anxiety Inventory (BAI)
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25.42 points
STANDARD_DEVIATION 9.61 • n=20 Participants
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PRIMARY outcome
Timeframe: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.Population: Fifteen participants were initially recruited. Three were excluded from the final analysis: two withdrew following the first day of aiTBS due to perceived worsening of nightmares and headaches, and one was excluded after abruptly discontinuing a prescribed anxiety medication and initiating a new medication.
The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety symptom severity. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
n=12 Participants
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
|
|---|---|
|
Beck Anxiety Inventory (BAI)
Baseline
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25.42 points
Standard Deviation 9.61
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|
Beck Anxiety Inventory (BAI)
Immediately Post-Treatment
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12.67 points
Standard Deviation 8.42
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Beck Anxiety Inventory (BAI)
1 Week Post-Treatment
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12.54 points
Standard Deviation 8.33
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Beck Anxiety Inventory (BAI)
2 Weeks Post-Treatment
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10.25 points
Standard Deviation 5.76
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Beck Anxiety Inventory (BAI)
1 Month Post-Treatment
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8.75 points
Standard Deviation 5.33
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SECONDARY outcome
Timeframe: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.Population: Fifteen participants were initially recruited. Three were excluded from the final analysis: two withdrew following the first day of aiTBS due to perceived worsening of nightmares and headaches, and one was excluded after abruptly discontinuing a prescribed anxiety medication and initiating a new medication.
BAI response was defined as a ≥50% reduction in Beck Anxiety Inventory (BAI) total score from baseline. Outcome values represent the number of participants who met this criterion at each assessment time point.
Outcome measures
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
n=12 Participants
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
|
|---|---|
|
BAI Response
2 Weeks Post-Treatment · 1 Month Post-Treatment
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8 Participants
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BAI Response
Baseline · 1 Month Post-Treatment
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0 Participants
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BAI Response
Immediately Post-Treatment · 1 Month Post-Treatment
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7 Participants
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BAI Response
1 Week Post-Treatment · 1 Month Post-Treatment
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7 Participants
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BAI Response
1 Month Post-Treatment · 1 Month Post-Treatment
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8 Participants
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SECONDARY outcome
Timeframe: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.Population: Fifteen participants were initially recruited. Three were excluded from the final analysis: two withdrew following the first day of aiTBS due to perceived worsening of nightmares and headaches, and one was excluded after abruptly discontinuing a prescribed anxiety medication and initiating a new medication.
The Hamilton Anxiety Rating Scale (HAMA) is a clinician-administered measure of anxiety symptom severity. The scale consists of 14 items rated from 0 (not present) to 4 (severe), yielding total scores ranging from 0 to 56, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
n=12 Participants
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
|
|---|---|
|
Hamilton Anxiety Rating Scale (HAMA)
Baseline
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25.92 points
Standard Deviation 8.39
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Hamilton Anxiety Rating Scale (HAMA)
Immediately Post-Treatment
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15.5 points
Standard Deviation 8.35
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Hamilton Anxiety Rating Scale (HAMA)
1 Week Post-Treatment
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15.25 points
Standard Deviation 9.28
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Hamilton Anxiety Rating Scale (HAMA)
2 Weeks Post-Treatment
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10.92 points
Standard Deviation 6.76
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Hamilton Anxiety Rating Scale (HAMA)
1 Month Post-Treatment
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11.08 points
Standard Deviation 7.29
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SECONDARY outcome
Timeframe: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.Population: Fifteen participants were initially recruited. Three were excluded from the final analysis: two withdrew following the first day of aiTBS due to perceived worsening of nightmares and headaches, and one was excluded after abruptly discontinuing a prescribed anxiety medication and initiating a new medication.
The Sheehan Disability Scale (SDS) is a self-report measure of functional impairment across work/school, social, and family life domains. Total scores range from 0 to 30, with higher scores indicating greater functional impairment.
Outcome measures
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
n=12 Participants
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
|
|---|---|
|
Sheehan Disability Scale (SDS)
1 Week Post-Treatment
|
11.58 points
Standard Deviation 6.58
|
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Sheehan Disability Scale (SDS)
2 Weeks Post-Treatment
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10.83 points
Standard Deviation 6.16
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Sheehan Disability Scale (SDS)
1 Month Post-Treatment
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10.67 points
Standard Deviation 6.46
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Sheehan Disability Scale (SDS)
Baseline
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20.33 points
Standard Deviation 3.47
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Sheehan Disability Scale (SDS)
Immediately Post-Treatment
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12.09 points
Standard Deviation 6.09
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Adverse Events
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-label aiTBS to Novel Right dmPFC TMS Anxiety Target
n=15 participants at risk
transcranial magnetic stimulation: non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
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|---|---|
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Eye disorders
blurred vision and diplopia
|
6.7%
1/15 • Number of events 1 • From initiation of aiTBS through the 1-month follow-up visit.
Adverse events and treatment-emergent side effects were monitored throughout treatment and follow-up.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place