EEG Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder

NCT06081309 | Completed Results DMC FDA Device

• 1 other identifier: eTMS-PTSD-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; Veterans; First Responders

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and Final Measure, between 10-21 Days

Secondary Outcomes (1)

• 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

Study Arms (1)

Open-Label active EEG-based personalized TMS treatment

EXPERIMENTAL

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

Interventions

EEG-based personalized TMS DEVICE

Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)

Open-Label active EEG-based personalized TMS treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (1)

Wright State University

Dayton, Ohio, 45435, United States

Location

Related Publications (27)

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Related Links

• Study Information Page

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

This was an open-label safety study. With no sham control, it is not possible to determine a statistically significant outcome.

Results Point of Contact

• Title: Bill Phillips
• Organization: Wave Neuroscience, Inc.

bill@waveneuro.com

714-883-7890

Study Officials

• Bill Phillips, PhD

  Wave Neuroscience, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label safety pilot study of EEG-based personalized TMS

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 13, 2023
• Study Start: November 20, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)