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

NCT ID: NCT06081309

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2024-05-16

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EEG-based personalized TMS

Intervention Type: DEVICE

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

Interventions

EEG-based personalized TMS

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wave Neuroscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bill Phillips, PhD

Role: PRINCIPAL_INVESTIGATOR

Wave Neuroscience, Inc.

Locations

Wright State University

Dayton, Ohio, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://etmsfda.com

Study Information Page

Other Identifiers

eTMS-PTSD-001

Identifier Type: -

Identifier Source: org_study_id