Trial Outcomes & Findings for Effect of rTMS on Anxiety (NCT NCT03993509)

Last Updated: 2025-01-23

Results Overview

Electromyography Facial electromyography (EMG) startle responses were recorded from the left orbicularis oculi muscle at 2000 Hz using a Biopac MP160 unit (Biopac; Goleta, CA) via 15 × 20 mm hydrogel coated vinyl electrodes (Rhythmlink #DECUS10026; Columbia, SC). Startle EMG was bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses were scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores with a mean of 50 and a standard deviation of 10 (tx = \[Zx × 10\] + 50). Greater t-scores mean larger blinks, which could be associated with greater anxiety, however there is no clinically relevent threshold. Noisy trials (baseline SD \> 2x run SD) were excluded, and "no blink" (peak \< baseline range) trials were coded as 0. To calculate APS, we subtracted the response during the neutral ITI from the response during the unpredictable ITI.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

Pre and 24-hours post stimulation

Results posted on

2025-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	cTBS Arm (Active/Sham) Subjects assigned to the cTBS Arm completed both an active and a sham period, separated by a 1-week break. Some subjects received the active period first, while other subjects received the sham period first. The period data below are collapsed across counterbalance. Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec. The active side of the coil was used for these sessions.	iTBS Arm (Active/Sham) Subjects assigned to the iTBS Arm completed both an active and a sham period, separated by a 1-week break. Some subjects received the active period first, while other subjects received the sham period first. The period data below are collapsed across counterbalance. Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS Arm (Sham/Active) Subjects assigned to the cTBS Arm completed both an active and a sham period, separated by a 1-week break. Some subjects received the active period first, while other subjects received the sham period first. The period data below are collapsed across counterbalance. Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec. The active side of the coil was used for these sessions.	iTBS (Sham/Active) Subjects assigned to the iTBS Arm completed both an active and a sham period, separated by a 1-week break. Some subjects received the active period first, while other subjects received the sham period first. The period data below are collapsed across counterbalance. Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.
Active STARTED	18	17	16	17
Active COMPLETED	15	16	13	14
Active NOT COMPLETED	3	1	3	3
Sham STARTED	15	16	13	14
Sham COMPLETED	15	16	13	12
Sham NOT COMPLETED	0	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of rTMS on Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	cTBS Arm n=28 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.	iTBS Arm n=28 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	Total n=56 Participants Total of all reporting groups
Age, Continuous	26.61 years STANDARD_DEVIATION 7.04 • n=5 Participants	23.75 years STANDARD_DEVIATION 4.26 • n=7 Participants	25.18 years STANDARD_DEVIATION 5.65 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre and 24-hours post stimulation

Outcome measures

Outcome measures
Measure	iTBS (Sham/Active) n=12 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS Arm n=15 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.	iTBS Arm (Active/Sham) n=16 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS (Sham/Active) n=13 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.
Anxiety Potentiated Startle active	4.848463905 T-scores Standard Deviation 2.77573715	4.600026484 T-scores Standard Deviation 3.690076704	3.411297242 T-scores Standard Deviation 4.494552916	3.122643391 T-scores Standard Deviation 4.286242167
Anxiety Potentiated Startle sham	3.551809142 T-scores Standard Deviation 4.504709597	2.098026426 T-scores Standard Deviation 3.687256948	1.347655375 T-scores Standard Deviation 5.091633437	3.063363512 T-scores Standard Deviation 4.002345814

PRIMARY outcome

Timeframe: Pre and 24 hours post stimulation

Electromyography Facial electromyography (EMG) startle responses were recorded from the left orbicularis oculi muscle at 2000 Hz using a Biopac MP160 unit (Biopac; Goleta, CA) via 15 × 20 mm hydrogel coated vinyl electrodes (Rhythmlink #DECUS10026; Columbia, SC). Startle EMG was bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses were scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores with a mean of 50 and a standard deviation of 10 (tx = \[Zx × 10\] + 50). Greater t-scores mean larger blinks, which could be associated with greater fear, however there is no clinically relevent threshold. Noisy trials (baseline SD \> 2x run SD) were excluded, and "no blink" (peak \< baseline range) trials were coded as 0. To calculate FPS, we subtracted the response during the predictable ITI from the response during the predictable Cue.

Outcome measures

Outcome measures
Measure	iTBS (Sham/Active) n=12 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS Arm n=15 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.	iTBS Arm (Active/Sham) n=16 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS (Sham/Active) n=13 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.
Fear Potentiated Startle active	5.529855023 T-scores Standard Error 4.175930826	7.598819444 T-scores Standard Error 4.007589756	6.719283178 T-scores Standard Error 5.508434373	6.564791401 T-scores Standard Error 4.771055896
Fear Potentiated Startle sham	6.496396165 T-scores Standard Error 3.242895129	5.61775824 T-scores Standard Error 3.484582125	3.016188249 T-scores Standard Error 6.334558956	6.651174586 T-scores Standard Error 5.405511643

PRIMARY outcome

Timeframe: Pre and 24 hours post stimulation

Sternberg task: On each WM trial, subjects will see a series of 4 letters presented singularly (encoding period) that will be followed by a brief interval where subjects are required to maintain these letters (maintenance period). At the end of the maintenance period, subjects will be prompted to make a response based on the task instructions (response period). The response prompt will consist of a letter and a number. The letter will be chosen from the study series, and the number will correspond to a position in the series. The subjects will indicate whether the position of the letter in the series matches the number.

Outcome measures

Outcome measures
Measure	iTBS (Sham/Active) n=12 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS Arm n=15 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.	iTBS Arm (Active/Sham) n=16 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS (Sham/Active) n=13 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.
Sternberg WM Accuracy active	87.45039683 percent correct Standard Deviation 10.42233406	80.70887446 percent correct Standard Deviation 15.81409388	86.99776786 percent correct Standard Deviation 10.46204331	84.89010989 percent correct Standard Deviation 13.40836505
Sternberg WM Accuracy sham	90.35218254 percent correct Standard Deviation 8.095574634	81.38888889 percent correct Standard Deviation 16.70756441	87.85342262 percent correct Standard Deviation 7.303273682	86.76739927 percent correct Standard Deviation 16.03952935

PRIMARY outcome

Timeframe: Responses are measured within the TMS/fMRI session in response to each TMS pulse and collapsed across trials. There is no sham condition. This session was typically conducted during the washout period, but varied depending upon participant schedule.

As with Experiment 1, subjects will have Neutral, Predictable, and Unpredictable periods. During the neutral periods, they will be safe from shocks. During the predictable periods, they can receive shocks but only when there is a cue present. During the unpredictable periods, they are at risk for shock during the entire duration of the block. Rather than probing their ongoing anxiety with the startle probes, we replaced the startle probes with single TMS pulses to the right dlPFC. This allowed us to causally examine the effect of right dlPFC activity (induced by the TMS pulse) on the neural activity. BOLD responses are collapsed across regions and conditions to examine right dlPFC BOLD down regulation.

Outcome measures

Outcome measures
Measure	iTBS (Sham/Active) Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS Arm n=22 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.	iTBS Arm (Active/Sham) n=19 Participants Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session.	cTBS (Sham/Active) Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.
TMS-evoked BOLD Responses	—	-0.0074 BOLD signal Standard Deviation 0.0056	-0.0063 BOLD signal Standard Deviation 0.0072	—

Adverse Events

Active cTBS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Active iTBS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sham cTBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham iTBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active cTBS n=34 participants at risk Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec. The active side of the coil was used for these sessions.	Active iTBS n=34 participants at risk Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session. The active side of the coil was used for these sessions.	Sham cTBS n=34 participants at risk Sham stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. cTBS parameters. During each cTBS session, a single 600 pulse cTBS train was delivered during each stimulation session at 100% of RMT. The train consisted of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec. The sham side of the coil was used for these sessions.	Sham iTBS n=34 participants at risk Active stimulation. A Magventure MagPro 100X stimulator with a B65AP (active/placebo) figure-8 coil was used for the cTBS sessions. The active and sham coil sides of the coil were masked and assigned blinded labels (e.g. A = active, B = sham). The label key was maintained by a member of the study staff not directly involved in the collection or analysis of the data. All other study staff were blinded to the label assignments. iTBS parameters. During each iTBS session, ten 60-pulse iTBS trains were delivered at 100% of RMT. The trains consisted of 3 50 Hz bursts repeated at intervals of 200 ms (5 Hz) for 2 seconds of stimulation separated by 8 second gaps, for a total of 600 pulses per session. The sham side of the coil was used for these sessions.
Product Issues Mild headache or jaw pain	8.8% 3/34 • Number of events 3 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event	5.9% 2/34 • Number of events 2 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event	0.00% 0/34 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event	0.00% 0/34 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event
Product Issues mild claustrophobia	0.00% 0/34 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event	2.9% 1/34 • Number of events 1 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event	0.00% 0/34 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event	0.00% 0/34 • 5 weeks An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is: fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity a congenital anomaly or birth defect, an important medical event

Additional Information

Nicholas Balderston

University of Pennsylvania

Phone: 2157463058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place