An interventional study of EEG-based personalized TMS in Stress Disorders, Post-Traumatic, sponsored by Wave Neuroscience. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Wave Neuroscience · Not applicable, Interventional, and Treatment
This is an open-label safety pilot study of the Electroencephalogram (EEG) Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 30 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 10 in-office visits that take place over 21 total days. Two eTMS treatment sessions are administered during each office visit.
eTMS-PTSD-001 is an open-label safety pilot study with a recruitment goal of 30 subjects, with 26 completers. The Study is intended to evaluate the safety aspects of eTMS in the target population. A maximum of 400 individuals will be screened in order to achieve the recruitment goal. The total number of days from the first participant enrolled to the last enrolled participant treated will be approximately 7 months.
Participants will be either Veterans or First Responders (e.g., emergency medical service provider, firefighter, or any other emergency response personnel), between 22-65 years of age. Participants may be male or female of any racial/ethnic background who meet the eligibility criteria. Participants will be recruited from the general public, and from veterans and first responder organizations.
The primary outcome for the Study will be the incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of adverse events during the study.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Wave Neuroscience is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: EEG-based personalized TMS
Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During 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
Time frame: Baseline and Final Measure, between 10-21 Days
Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)
The 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.
Time frame: Baseline and Final Measure, between 10-21 Days
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.
| Milestone | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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
| Number of AEs | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Adverse Event Intensity - Mild | 26 |
| Adverse Event Intensity - Moderate | 3 |
| Adverse Event Intensity - Severe | 2 |
| Adverse Event Relationship to Treatment - Not Related | 17 |
| Adverse Event Relationship to Treatment - Suspected | 5 |
| Adverse Event Relationship to Treatment - Definitely Related | 9 |
| Serious Adverse Event | 0 |
| Not a Serious Adverse Event | 31 |
| Subsequent treatment/intervention required | 0 |
| No subsequent treatment/required | 31 |
The 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.
| score on a scale | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Baseline Measure | 52.2 ± 8.9 |
| Final Measure | 22.9 ± 14.0 |
| Change between Baseline and Final Measure | 29.3 ± 13.1 |
The number of participants who experienced at least one Adverse Event in the study
| Participants | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Number of Participants With at Least One Adverse Event | 14 |
Collected over Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-Label Active EEG-based Personalized TMS Treatment | 0/30 (0%) | 0/30 (0%) | 14/30 (46.7%) |
| Event | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| HeadacheGeneral disorders | 9/30 |
| Mild HeadacheGeneral disorders | 7/30 |
| Sinus HeadacheGeneral disorders | 4/30 |
| NauseaGastrointestinal disorders | 3/30 |
| IrritabilityGeneral disorders | 2/30 |
| Mild Head ColdGeneral disorders | 2/30 |
| BruiseGeneral disorders | 1/30 |
| Short-term SadnessNervous system disorders | 1/30 |
| Local Site PainSkin and subcutaneous tissue disorders | 1/30 |
| ConjunctivitisEye disorders | 1/30 |
| Age, Continuous(years) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Mean | 42.7 ± 9.5 |
| Sex: Female, Male(Participants) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Female | 6 |
| Male | 24 |
| Ethnicity (NIH/OMB)(Participants) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 28 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 25 |
| More than one race | 3 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| United States | 30 |
| Education Level(Participants) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Less than 9th Grade | 0 |
| 9th - 12th Grade, No Diploma | 0 |
| High School Diploma or Equivalent | 0 |
| Some College, No Degree | 7 |
| Associate Degree | 9 |
| Bachelor's Degree | 9 |
| Graduate or Professional Degree | 5 |
| Marital Status(Participants) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Never Married | 3 |
| Separated | 0 |
| Married | 21 |
| Divorced | 5 |
| Widowed | 1 |
| Military/First Responder(participants) | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Military - Reservist | 0 |
| Military - National Guard | 0 |
| Military - Retiree | 3 |
| Military - Veteran | 19 |
| 1st Responder - Emergency Medical | 0 |
| 1st Responder - Firefighter | 4 |
| 1st Responder - Police | 6 |
| 1st Responder - Search and Rescue | 0 |
| 1st Responder - Crisis Counselor | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual Participant Data will not be shared with other researchers
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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