Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study (NCT NCT02231892)

Last Updated: 2020-02-24

Results Overview

Behavioral effects of INTENSITY (Sham/100%MT/110%MT) and demand for cognitive control, DEMAND (High/Medium/Low), were planned to be quantified via correct response time (RT) and trial accuracy using R Project for Statistical Computing (package afex, function mixed (Singmannet al, 2015)). RT data were planned to be submitted to a linear mixed model with a random intercept per subject and fixed effects of INTENSITY and DEMAND. Accuracy data were planned to be submitted to a generalized linear mixed model with a binomial distribution and logit link function with a random intercept per subject and fixed effects of INTENSITY and DEMAND. During the Behavioral phase of the study, this data was collected before TMS, immediately after TMS, and 1 hour after TMS. During the MRI phase of the study, this data was only collected before TMS and immediately after TMS.

Recruitment status

COMPLETED

Study phase

Target enrollment

104 participants

Primary outcome timeframe

3x per session in Behavioral phase (before TMS, immediately after TMS, and 1 hour after TMS), and 2x per session in MRI Phase (before TMS and immediately after TMS).

Results posted on

2020-02-24

Participant Flow

Orientation occurred prior to starting repetitive transcranial magnetic stimulation (rTMS) days. Orientation consisted of single-pulse TMS (allowed participant to experience TMS and researcher to find motor hotspot) and habituation (allowed participant to habituate to varied TMS intensities). Many ppts withdrew or were excluded during orientation.

Participant milestones

Participant milestones
Measure	Low Frequency rTMS - Behavioral Phase Participants in this arm received sham or active 1 hertz (Hz) rTMS at 100% and 110% of motor threshold during the behavioral phase.	High Frequency rTMS - Behavioral Phase Participants in this arm received sham or active 10 hertz (Hz) rTMS at 100% and 110% of motor threshold during the behavioral phase	High Frequency rTMS - MRI Phase Participants in this arm received sham or active 10 hertz (Hz) rTMS at 100% and 110% of motor threshold during the MRI phase of the study.
Overall Study STARTED	17	17	70
Overall Study Sham	8	5	26
Overall Study 100% MT	7	6	25
Overall Study 110% MT	7	5	27
Overall Study COMPLETED	6	5	25
Overall Study NOT COMPLETED	11	12	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Frequency rTMS - Behavioral Phase Participants in this arm received sham or active 1 hertz (Hz) rTMS at 100% and 110% of motor threshold during the behavioral phase.	High Frequency rTMS - Behavioral Phase Participants in this arm received sham or active 10 hertz (Hz) rTMS at 100% and 110% of motor threshold during the behavioral phase	High Frequency rTMS - MRI Phase Participants in this arm received sham or active 10 hertz (Hz) rTMS at 100% and 110% of motor threshold during the MRI phase of the study.
Overall Study Lost to Follow-up	1	0	3
Overall Study Withdrawal by Subject	4	3	15
Overall Study Physician Decision	0	2	4
Overall Study Motor activity when stimulating ante ACC	4	7	12
Overall Study Participant motor threshold was >83%	0	0	9
Overall Study Could not find motor threshold	2	0	1
Overall Study Could not find reliable motor hotspot	0	0	1

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Frequency rTMS - Behavioral Phase n=17 Participants Participants in this arm received sham or active 1Hz rTMS at 100% and 110% of motor threshold during the behavioral phase	High Frequency rTMS - Behavioral Phase n=17 Participants Participants in this arm received sham or active 10Hz rTMS at 100% and 110% of motor threshold during the behavioral phase	High Frequency rTMS - MRI Phase n=70 Participants Participants in this arm received sham or active 10Hz rTMS at 100% and 110% of motor threshold during the MRI phase of the study.	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	68 Participants n=5 Participants	102 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30.12 years n=5 Participants	28.55 years n=7 Participants	32.39 years n=5 Participants	31.27 years n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	39 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	31 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	64 Participants n=5 Participants	94 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants	62 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	25 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	70 participants n=5 Participants	104 participants n=4 Participants

PRIMARY outcome

Timeframe: 3x per session in Behavioral phase (before TMS, immediately after TMS, and 1 hour after TMS), and 2x per session in MRI Phase (before TMS and immediately after TMS).

Population: Data have not yet been analyzed due to personnel turnover. There are currently no resources to complete data analysis at this time. We have transferred data to a repository protocol for future analysis when resources for data analysis are available.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Twice per session in MRI Phase (pre-TMS and immediately post-TMS)

These measures include resting state (seed-based functional connectivity), Arterial Spin labeling (ASL), and MRI Spectroscopy (MRS). 1. Seed based - correlation coefficient changes 2. ASL - % change 3. MRS - % change

Outcome measures

Other adverse events

Other adverse events
Measure	Low Frequency rTMS - 100% MT - Behavioral Phase n=7 participants at risk Active 1Hz rTMS at 100% of motor threshold during the behavioral phase	Low Frequency rTMS - 110% MT - Behavioral Phase n=7 participants at risk Active 1Hz rTMS at 110% of motor threshold during the behavioral phase	Low Frequency rTMS - Sham - Behavioral Phase n=8 participants at risk Low Frequency rTMS, sham, during behavioral phase.	High Frequency rTMS - 100% MT - Behavioral Phase n=6 participants at risk Active 10Hz rTMS at 100% of motor threshold during the behavioral phase	High Frequency rTMS - 110% MT - Behavioral Phase n=5 participants at risk Active 10Hz rTMS at 110% of motor threshold during the behavioral phase	High Frequency rTMS - Sham - Behavioral Phase n=5 participants at risk High Frequency rTMS, sham, during behavioral phase.	High Frequency rTMS - 100% MT - MRI Phase n=25 participants at risk Active 10Hz rTMS at 100% of motor threshold during the MRI phase of the study.	High Frequency rTMS - 110% MT - MRI Phase n=27 participants at risk Active 10Hz rTMS at 110% of motor threshold during the MRI phase of the study.	High Frequency rTMS - Sham - MRI Phase n=26 participants at risk High Frequency rTMS, sham, during MRI phase.
General disorders Headache	42.9% 3/7 • Number of events 3 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	14.3% 1/7 • Number of events 1 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/8 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/6 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/25 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/27 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/26 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.
General disorders Headache and Dizziness	14.3% 1/7 • Number of events 1 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/7 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/8 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/6 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	4.0% 1/25 • Number of events 1 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	7.4% 2/27 • Number of events 2 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/26 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.
Psychiatric disorders Hypomanic Episode	0.00% 0/7 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/7 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/8 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/6 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	4.0% 1/25 • Number of events 1 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/27 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/26 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.
Nervous system disorders Involuntary Movement After TMS	14.3% 1/7 • Number of events 1 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/7 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/8 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/6 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/5 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	4.0% 1/25 • Number of events 1 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/27 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.	0.00% 0/26 • Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment. AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.

Additional Information

Dr. Elliott Stein

National Institute on Drug Abuse

Phone: 443-740-2650

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place