Trial Outcomes & Findings for EEG Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder (NCT NCT06081309)
NCT ID: NCT06081309
Last Updated: 2025-03-19
Results Overview
Number - Number of adverse events reported. Note that each participant may have had more than one adverse event (AE). Severity - Number of adverse events that were mild, moderate, or severe. Relatedness - Number of adverse events that were not related, suspected, or definitely related to treatment. Type - Number of adverse events that were or were not Serious Adverse Events (SAEs). Subsequent treatment/intervention required - Number of adverse events that did or did not require subsequent treatment/intervention. Number of participants reporting at least one AE
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline and Final Measure, between 10-21 Days
Results posted on
2025-03-19
Participant Flow
The eTMS-PTSD-001 study is divided into two stages: (Stage 1) An Open-Label safety pilot study; and (Stage 2) a randomized double-blind sham-controlled study. The current record (NCT06081309) covers only Stage 1. The study details and results for Stage 2 of the study will be reported in a separate record.
Participant milestones
| Measure |
Open-Label Active EEG-based Personalized TMS Treatment
20 sessions of EEG-based personalized TMS over a maximum of 21 days. Two sessions per treatment day. Each session consists of TMS treatment at 50% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.
EEG-based personalized TMS: Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EEG Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Open-Label Active EEG-based Personalized TMS Treatment
n=30 Participants
20 sessions of EEG-based personalized TMS over a maximum of 21 days. Two sessions per treatment day. Each session consists of TMS treatment at 50% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.
EEG-based personalized TMS: Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
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|---|---|
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Age, Continuous
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42.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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30 participants
n=5 Participants
|
|
Education Level
Less than 9th Grade
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0 Participants
n=5 Participants
|
|
Education Level
9th - 12th Grade, No Diploma
|
0 Participants
n=5 Participants
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|
Education Level
High School Diploma or Equivalent
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0 Participants
n=5 Participants
|
|
Education Level
Some College, No Degree
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7 Participants
n=5 Participants
|
|
Education Level
Associate Degree
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9 Participants
n=5 Participants
|
|
Education Level
Bachelor's Degree
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9 Participants
n=5 Participants
|
|
Education Level
Graduate or Professional Degree
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5 Participants
n=5 Participants
|
|
Marital Status
Never Married
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3 Participants
n=5 Participants
|
|
Marital Status
Separated
|
0 Participants
n=5 Participants
|
|
Marital Status
Married
|
21 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
5 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=5 Participants
|
|
Military/First Responder
Military - Reservist
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0 participants
n=5 Participants
|
|
Military/First Responder
Military - National Guard
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0 participants
n=5 Participants
|
|
Military/First Responder
Military - Retiree
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3 participants
n=5 Participants
|
|
Military/First Responder
Military - Veteran
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19 participants
n=5 Participants
|
|
Military/First Responder
1st Responder - Emergency Medical
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0 participants
n=5 Participants
|
|
Military/First Responder
1st Responder - Firefighter
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4 participants
n=5 Participants
|
|
Military/First Responder
1st Responder - Police
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6 participants
n=5 Participants
|
|
Military/First Responder
1st Responder - Search and Rescue
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0 participants
n=5 Participants
|
|
Military/First Responder
1st Responder - Crisis Counselor
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0 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and Final Measure, between 10-21 DaysPopulation: Analyzed the total number of Adverse Events (AEs) that occurred in the study.
Number - Number of adverse events reported. Note that each participant may have had more than one adverse event (AE). Severity - Number of adverse events that were mild, moderate, or severe. Relatedness - Number of adverse events that were not related, suspected, or definitely related to treatment. Type - Number of adverse events that were or were not Serious Adverse Events (SAEs). Subsequent treatment/intervention required - Number of adverse events that did or did not require subsequent treatment/intervention. Number of participants reporting at least one AE
Outcome measures
| Measure |
Open-Label Active EEG-based Personalized TMS Treatment
n=31 AEs
20 sessions of EEG-based personalized TMS over a maximum of 21 days. Two sessions per treatment day. Each session consists of TMS treatment at 50% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.
EEG-based personalized TMS: Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
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|---|---|
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Adverse Event Intensity - Mild
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26 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Adverse Event Intensity - Moderate
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3 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Adverse Event Intensity - Severe
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2 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Adverse Event Relationship to Treatment - Not Related
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17 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Adverse Event Relationship to Treatment - Suspected
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5 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Adverse Event Relationship to Treatment - Definitely Related
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9 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Serious Adverse Event
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0 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Not a Serious Adverse Event
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31 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Subsequent treatment/intervention required
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0 Number of AEs
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Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
No subsequent treatment/required
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31 Number of AEs
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SECONDARY outcome
Timeframe: Baseline and Final Measure, between 10-21 DaysThe Post Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5), commonly referred to as PCL-5, is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to monitor symptom change during and after treatment. Each item is scored from 0 to 5 as the participant's estimate of the severity of the symptom (0 = Not at all, 1=A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). The final score range is between 0-80. A lower score is considered better than a higher score.
Outcome measures
| Measure |
Open-Label Active EEG-based Personalized TMS Treatment
n=30 Participants
20 sessions of EEG-based personalized TMS over a maximum of 21 days. Two sessions per treatment day. Each session consists of TMS treatment at 50% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.
EEG-based personalized TMS: Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
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|---|---|
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Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)
Baseline Measure
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52.2 score on a scale
Standard Deviation 8.9
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Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)
Final Measure
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22.9 score on a scale
Standard Deviation 14.0
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Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)
Change between Baseline and Final Measure
|
29.3 score on a scale
Standard Deviation 13.1
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POST_HOC outcome
Timeframe: Baseline and Final Measure, between 10-21 DaysPopulation: Analyzed the total number of participants with at least one Adverse Event (AE) in the study.
The number of participants who experienced at least one Adverse Event in the study
Outcome measures
| Measure |
Open-Label Active EEG-based Personalized TMS Treatment
n=30 Participants
20 sessions of EEG-based personalized TMS over a maximum of 21 days. Two sessions per treatment day. Each session consists of TMS treatment at 50% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.
EEG-based personalized TMS: Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
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|---|---|
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Number of Participants With at Least One Adverse Event
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14 Participants
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Adverse Events
Open-Label Active EEG-based Personalized TMS Treatment
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-Label Active EEG-based Personalized TMS Treatment
n=30 participants at risk
20 sessions of EEG-based personalized TMS over a maximum of 21 days. Two sessions per treatment day. Each session consists of TMS treatment at 50% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.
EEG-based personalized TMS: Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
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|---|---|
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General disorders
Headache
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30.0%
9/30 • Number of events 9 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
|
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General disorders
Mild Headache
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23.3%
7/30 • Number of events 7 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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General disorders
Sinus Headache
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13.3%
4/30 • Number of events 4 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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Gastrointestinal disorders
Nausea
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10.0%
3/30 • Number of events 3 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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General disorders
Irritability
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6.7%
2/30 • Number of events 2 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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General disorders
Mild Head Cold
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6.7%
2/30 • Number of events 2 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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General disorders
Bruise
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3.3%
1/30 • Number of events 1 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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Nervous system disorders
Short-term Sadness
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3.3%
1/30 • Number of events 1 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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Skin and subcutaneous tissue disorders
Local Site Pain
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3.3%
1/30 • Number of events 1 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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Eye disorders
Conjunctivitis
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3.3%
1/30 • Number of events 1 • Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.
In the study, some participants experienced more than one Adverse Event. Therefore, in the table, the total number of Adverse Events listed is greater than the number of participants experiencing an Adverse Event.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place