Stress Disorders, Post-Traumatic
Conditions
Keywords
PTSD, Veterans, First Responders
Brief summary
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.
Detailed description
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.
Interventions
Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
Sponsors
Wave Neuroscience
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label safety pilot study of EEG-based personalized TMS
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Willing and able to consent to participate in the study via signed Informed Consent * Age 22 - 65 years * Provisional diagnosis of PTSD * Positive identification as either a Veteran, or First Responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel)
Exclusion criteria
* Uncontrolled medical, psychological or neurological condition * Pregnant, or female unwilling to use effective birth control during the course of the trial * Metal objects implanted in the head * Past exposure to metal fragments or other metal sources in the head and neck * Current participation in any interventional research protocol * History of any type of Electroconvulsive Therapy (ECT) or TMS * History of stroke or intracranial lesion, or increased intracranial pressure * History or epilepsy or seizure * Family history of epilepsy or seizure in 1st degree relative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Baseline and Final Measure, between 10-21 Days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5) | Baseline and Final Measure, between 10-21 Days | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Open-Label Active EEG-based Personalized TMS Treatment |
|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 9.5 |
| Education Level 9th - 12th Grade, No Diploma | 0 Participants |
| Education Level Associate Degree | 9 Participants |
| Education Level Bachelor's Degree | 9 Participants |
| Education Level Graduate or Professional Degree | 5 Participants |
| Education Level High School Diploma or Equivalent | 0 Participants |
| Education Level Less than 9th Grade | 0 Participants |
| Education Level Some College, No Degree | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Marital Status Divorced | 5 Participants |
| Marital Status Married | 21 Participants |
| Marital Status Never Married | 3 Participants |
| Marital Status Separated | 0 Participants |
| Marital Status Widowed | 1 Participants |
| Military/First Responder 1st Responder - Crisis Counselor | 0 participants |
| Military/First Responder 1st Responder - Emergency Medical | 0 participants |
| Military/First Responder 1st Responder - Firefighter | 4 participants |
| Military/First Responder 1st Responder - Police | 6 participants |
| Military/First Responder 1st Responder - Search and Rescue | 0 participants |
| Military/First Responder Military - National Guard | 0 participants |
| Military/First Responder Military - Reservist | 0 participants |
| Military/First Responder Military - Retiree | 3 participants |
| Military/First Responder Military - Veteran | 19 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 14 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
Population: Analyzed the total number of Adverse Events (AEs) that occurred in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Adverse Event Intensity - Mild | 26 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Adverse Event Intensity - Moderate | 3 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Adverse Event Intensity - Severe | 2 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | 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 | 17 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Adverse Event Relationship to Treatment - Suspected | 5 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | 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 | 9 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Serious Adverse Event | 0 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Not a Serious Adverse Event | 31 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | Subsequent treatment/intervention required | 0 Number of AEs |
| Open-Label Active EEG-based Personalized TMS Treatment | Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. | No subsequent treatment/required | 31 Number of AEs |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open-Label Active EEG-based Personalized TMS Treatment | Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5) | Baseline Measure | 52.2 score on a scale | Standard Deviation 8.9 |
| Open-Label Active EEG-based Personalized TMS Treatment | Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5) | Final Measure | 22.9 score on a scale | Standard Deviation 14 |
| Open-Label Active EEG-based Personalized TMS Treatment | 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 |
Post Hoc
Number of Participants With at Least One Adverse Event
The number of participants who experienced at least one Adverse Event in the study
Time frame: Baseline and Final Measure, between 10-21 Days
Population: Analyzed the total number of participants with at least one Adverse Event (AE) in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open-Label Active EEG-based Personalized TMS Treatment | Number of Participants With at Least One Adverse Event | 14 Participants |