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

Sponsor
Wave Neuroscience (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06081309
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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 20 in-office treatments over 35 days.

Condition or Disease Intervention/Treatment Phase
  • Device: EEG-based personalized TMS
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is an open-label safety pilot study of EEG-based personalized TMSThis is an open-label safety pilot study of EEG-based personalized TMS
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open-Label active EEG-based personalized TMS treatment

20 sessions of EEG-based personalized TMS over a maximum of 35 days. One session maximum per 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.

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

Outcome Measures

Primary Outcome Measures

  1. Treatment Safety [Assessed at all treatment sessions and Follow-up Visit, a duration of up to 5 weeks]

    Incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of adverse events during the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wright State University Dayton Ohio United States 45435

Sponsors and Collaborators

  • Wave Neuroscience

Investigators

  • Principal Investigator: Bill Phillips, PhD, Wave Neuroscience, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Wave Neuroscience
ClinicalTrials.gov Identifier:
NCT06081309
Other Study ID Numbers:
  • eTMS-PTSD-001
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Wave Neuroscience
PTSD
Veterans
First Responders
Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Oct 16, 2023