N/A N=30 Treatment

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

Stress Disorders, Post-Traumatic

Bottom Line

View on ClinicalTrials.gov: NCT06081309 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. — 26; 3; 2; 17 Number of AEs

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EEG-based personalized TMS (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Wave Neuroscience
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.	26; 3; 2; 17; 5; 9	—
SECONDARY Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)	52.2; 22.9; 29.3	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06081309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.