Trial Outcomes & Findings for Effect of TMS on PTSD Biomarkers (NCT NCT04563078)
NCT ID: NCT04563078
Last Updated: 2026-06-01
Results Overview
Amygdala reactivity during fear processing were assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity was measured. The amygdala was separated in the right and left hemispheres. fMRI measures the blood oxygen level-dependent response, a measure of how much more oxygenated blood there is in a certain brain region, which reflects activation of the brain region. A regression model was used to determine the beta value as a measure of brain activity. Across voxels in each region (right amygdala, left amygdala), the beta value for response in the amygdala to Fearful faces and Neutral faces was extracted.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline, day 10
Results posted on
2026-06-01
Participant Flow
After confirming eligibility (≥3 DSM-5 PTSD criteria using CAPS-5), 5 participants were excluded for not meeting PTSD criteria, 1 for Bipolar I on diagnostic assessment, and 2 for neurological exclusions. Additionally, 5 participants withdrew before randomization. A total of 50 participants were randomized to active or sham TMS.
Participant milestones
| Measure |
Transcranial Magnetic Stimulation (TMS)
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
Sham Transcranial Magnetic Stimulation (TMS)
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Transcranial Magnetic Stimulation (TMS)
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
Sham Transcranial Magnetic Stimulation (TMS)
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Effect of TMS on PTSD Biomarkers
Baseline characteristics by cohort
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=26 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
Sham Transcranial Magnetic Stimulation (TMS)
n=24 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
50 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
43 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
44 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
15 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
30 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Baseline, day 10Amygdala reactivity during fear processing were assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity was measured. The amygdala was separated in the right and left hemispheres. fMRI measures the blood oxygen level-dependent response, a measure of how much more oxygenated blood there is in a certain brain region, which reflects activation of the brain region. A regression model was used to determine the beta value as a measure of brain activity. Across voxels in each region (right amygdala, left amygdala), the beta value for response in the amygdala to Fearful faces and Neutral faces was extracted.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=20 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=24 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment
Baseline: Right
|
0.188 BOLD signal
Standard Deviation 0.158
|
0.219 BOLD signal
Standard Deviation 0.248
|
|
Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment
Baseline: Left
|
0.138 BOLD signal
Standard Deviation 0.222
|
0.166 BOLD signal
Standard Deviation 0.204
|
|
Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment
Post TMS (Day 10): Right
|
0.174 BOLD signal
Standard Deviation 0.262
|
0.117 BOLD signal
Standard Deviation 0.243
|
|
Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment
Post TMS (Day 10): Left
|
0.204 BOLD signal
Standard Deviation 0.311
|
0.151 BOLD signal
Standard Deviation 0.212
|
PRIMARY outcome
Timeframe: Baseline, day 10Population: A technical issue with the recording system-specifically, electrical noise-resulted in unusable recordings for one timepoint.
Change in skin conductance response to trauma cues pre- to post-treatment was assessed. The mobile skin conductance response was measured in microsiemens when participants described their worst trauma, followed by assessment of their symptoms. A numeric value estimating the skin conductance response was calculated by subtracting the baseline skin conductance reactivity from the reactivity during the trauma description.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=21 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=23 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Skin Conductance Response to Trauma Cues Pre- to Post-treatment
Baseline
|
0.442 microsiemens
Standard Deviation 0.549
|
0.757 microsiemens
Standard Deviation 0.963
|
|
Change in Skin Conductance Response to Trauma Cues Pre- to Post-treatment
Post TMS (Day 10)
|
0.370 microsiemens
Standard Deviation 0.350
|
0.721 microsiemens
Standard Deviation 0.839
|
SECONDARY outcome
Timeframe: Baseline, day 10Change in inhibition-related activation in the vmPFC was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli. At the same time, reactivity in the ventromedial prefrontal cortex was measured. Across voxels in the ventromedial prefrontal cortex, a contrast estimate of responses to Fearful \> Neutral faces was extracted. This is being reported as a numeric value estimating inhibition-related brain activation (contrast estimate fear versus neutral)
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=20 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=24 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Inhibition-related Activation in the Ventromedial Prefrontal Cortex (vmPFC) Pre- to Post-treatment
Post TMS (Day 10)
|
0.016 BOLD signal difference
Standard Deviation 0.134
|
-0.005 BOLD signal difference
Standard Deviation 0.215
|
|
Change in Inhibition-related Activation in the Ventromedial Prefrontal Cortex (vmPFC) Pre- to Post-treatment
Baseline
|
-0.025 BOLD signal difference
Standard Deviation 0.162
|
-0.065 BOLD signal difference
Standard Deviation 0.180
|
SECONDARY outcome
Timeframe: Baseline, day 10Change in inhibition-related activation in the hippocampus was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while hippocampal reactivity was measured. The hippocampus was separated into the right and left hemispheres. Across voxels in each region (right hippocampus, left hippocampus), a contrast estimate of Fearful \> Neutral faces was extracted.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=20 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=24 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Inhibition-related Activation in the Hippocampus Pre- to Post-treatment
Post TMS (day 10): Right
|
0.009 BOLD signal difference
Standard Deviation 0.080
|
-0.018 BOLD signal difference
Standard Deviation 0.102
|
|
Change in Inhibition-related Activation in the Hippocampus Pre- to Post-treatment
Post TMS (day 10): Left
|
0.021 BOLD signal difference
Standard Deviation 0.080
|
-0.027 BOLD signal difference
Standard Deviation 0.111
|
|
Change in Inhibition-related Activation in the Hippocampus Pre- to Post-treatment
Baseline: Right
|
-0.041 BOLD signal difference
Standard Deviation 0.116
|
-0.033 BOLD signal difference
Standard Deviation 0.086
|
|
Change in Inhibition-related Activation in the Hippocampus Pre- to Post-treatment
Baseline : Left
|
-0.028 BOLD signal difference
Standard Deviation 0.121
|
-0.035 BOLD signal difference
Standard Deviation 0.093
|
SECONDARY outcome
Timeframe: Baseline, day 10Change in vmPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the vmPFC and amygdala was measured.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=20 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=24 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Ventromedial Prefrontal Cortex (vmPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Baseline
|
0.000 correlation coefficient
Standard Deviation 0.042
|
-0.006 correlation coefficient
Standard Deviation 0.070
|
|
Change in Ventromedial Prefrontal Cortex (vmPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Post TMS (Day 10)
|
0.004 correlation coefficient
Standard Deviation 0.042
|
-0.021 correlation coefficient
Standard Deviation 0.062
|
SECONDARY outcome
Timeframe: Baseline, day 10Change in DLPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the DLPFC and amygdala was measured.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=20 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=24 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Dorsolateral Prefrontal Cortex (DLPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Baseline
|
-0.027 correlation coefficient
Standard Deviation 0.065
|
0.021 correlation coefficient
Standard Deviation 0.071
|
|
Change in Dorsolateral Prefrontal Cortex (DLPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Post TMS (Day 10)
|
-0.020 correlation coefficient
Standard Deviation 0.061
|
0.006 correlation coefficient
Standard Deviation 0.070
|
SECONDARY outcome
Timeframe: Baseline, day 10 (Post TMS)Population: One participant in the Sham group could not tolerate it, and for the rest of the missing participants, the equipment malfunctioned. Therefore, the data on these participants was not collected.
Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, one symbol followed by an airblast to the throat was the danger cue and a different symbol not followed by the airblast was the safety cue. The eye blink response in response to danger and safety cues was measured.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=21 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=25 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment.
Baseline :Safety
|
13.47 microvolt
Standard Deviation 33.77
|
14.10 microvolt
Standard Deviation 28.09
|
|
Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment.
Post TMS (Day 10): Danger
|
30.44 microvolt
Standard Deviation 33.93
|
36.45 microvolt
Standard Deviation 34.67
|
|
Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment.
Baseline: Danger
|
28.33 microvolt
Standard Deviation 32.86
|
41.76 microvolt
Standard Deviation 42.34
|
|
Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment.
Post TMS (Day 10): Safety
|
4.40 microvolt
Standard Deviation 31.65
|
0.31 microvolt
Standard Deviation 21.97
|
SECONDARY outcome
Timeframe: Baseline, day 10Population: One participant in the Sham group could not tolerate it, and for the rest of the missing participants, the equipment malfunctioned. Therefore, the data on these participants was not collected.
Change in discrimination between danger and safety cues pre- to post-treatment was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, with one symbol followed by an airblast to the throat serving as the danger cue, and a different symbol, not followed by the airblast, serving as the safety cue. The eye blink response in response to danger and safety cues was measured. The difference score for the eye blink response to danger and safety was calculated.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=21 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=25 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Discrimination Between Danger and Safety Cues Pre- to Post-treatment
Baseline
|
14.86 microvolt
Standard Deviation 41.50
|
27.63 microvolt
Standard Deviation 41.83
|
|
Change in Discrimination Between Danger and Safety Cues Pre- to Post-treatment
Post TMS (Day 10)
|
26.03 microvolt
Standard Deviation 52.00
|
36.14 microvolt
Standard Deviation 43.23
|
SECONDARY outcome
Timeframe: Baseline, day 10The severity of self-reported PTSD hyperarousal symptoms was assessed with the PCL-5, sub-cluster E. The PCL-5 asks participants to recall the worst stressful event that is currently bothering them the most. Keeping this event in mind, participants respond to 20 questions indicating how bothered they have been by PTSD symptoms. Responses are on a 5-point scale, where 0 = not bothered at all and 4 = extremely bothered. The 6 questions related to hyperarousal were used. Total raw scores range from 0 to 24, where higher scores indicate greater distress from PTSD hyperarousal symptoms.
Outcome measures
| Measure |
Sham Transcranial Magnetic Stimulation (TMS)
n=22 Participants
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
Transcranial Magnetic Stimulation (TMS)
n=25 Participants
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
|---|---|---|
|
Change in Post-traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Pre- to Post-treatment
Post TMS (Day 10)
|
8.09 score on a scale
Standard Deviation 5.58
|
7.92 score on a scale
Standard Deviation 4.51
|
|
Change in Post-traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Pre- to Post-treatment
Baseline
|
10.54 score on a scale
Standard Deviation 4.15
|
11.16 score on a scale
Standard Deviation 4.43
|
Adverse Events
Transcranial Magnetic Stimulation (TMS)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Sham Transcranial Magnetic Stimulation (TMS)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=26 participants at risk
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
|
Sham Transcranial Magnetic Stimulation (TMS)
n=24 participants at risk
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Sham Transcranial Magnetic Stimulation (TMS): 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Finger fracture
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Nervous system disorders
Electrical Shock sensation
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Gastrointestinal disorders
Difficulty swalloing
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Hips "burning"
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Blood and lymphatic system disorders
Nose bleeds
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Abdominal surgery (Hernia)
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Infections and infestations
Bronchitis with pneumonia
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Eye twitch
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Skin and subcutaneous tissue disorders
Rash on head and face
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Immune system disorders
Lupus
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Cardiac disorders
Heart pounding
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Musculoskeletal and connective tissue disorders
Muscle twitches (triceps)
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Numbness and tingling sensation
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Decreased appetite
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Panic attack
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Legs "burning"
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Musculoskeletal and connective tissue disorders
Hand Spasm
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Weight loss
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Wrist sprain
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Emotional burnout
|
7.7%
2/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Flashbacks
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Worsening affect
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Nighttime hallucinations
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Racing thoughts/ Rumination
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Panic attack (psychological symptoms)
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Paranoia
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Increased impulsivity
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Pessimism
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Disordered eating behaviors (binging & purging)
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Headaches (non migraine)
|
11.5%
3/26 • Data was collected from Baseline to Day 10th of the study
|
12.5%
3/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Fatigue
|
11.5%
3/26 • Data was collected from Baseline to Day 10th of the study
|
12.5%
3/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Reduced sleep
|
15.4%
4/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Nausea
|
7.7%
2/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Nervous system disorders
Balance difficulty
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Light headedness
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Infections and infestations
Flu
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Ear and labyrinth disorders
Tonsilitis
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Musculoskeletal and connective tissue disorders
Muscle tension
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
0.00%
0/24 • Data was collected from Baseline to Day 10th of the study
|
|
Nervous system disorders
Migraines
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Car accident
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Cold sore
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Eye disorders
Eye pain
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Nervous system disorders
Nerve pain
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Restlessness
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis flare up
|
0.00%
0/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Increased anxiety
|
26.9%
7/26 • Data was collected from Baseline to Day 10th of the study
|
16.7%
4/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Worsening depression
|
19.2%
5/26 • Data was collected from Baseline to Day 10th of the study
|
12.5%
3/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Increased sensitivity
|
15.4%
4/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Irritability
|
15.4%
4/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Increased stress
|
11.5%
3/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Nightmares
|
7.7%
2/26 • Data was collected from Baseline to Day 10th of the study
|
8.3%
2/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Increased emotional reactivity
|
7.7%
2/26 • Data was collected from Baseline to Day 10th of the study
|
4.2%
1/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Feeling overwhelmed
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
8.3%
2/24 • Data was collected from Baseline to Day 10th of the study
|
|
Psychiatric disorders
Increased dissociation
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
8.3%
2/24 • Data was collected from Baseline to Day 10th of the study
|
|
General disorders
Mental fogginess
|
3.8%
1/26 • Data was collected from Baseline to Day 10th of the study
|
8.3%
2/24 • Data was collected from Baseline to Day 10th of the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place