Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS4Stress)

Marcia Bockbrader, MD PhD

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Trauma and Stressor Related Disorders

Treatments

Device: Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05835414

BEP-001

Details and patient eligibility

About

The goal of this clinical trial is to learn about the safety, feasibility, and preliminary efficacy of EEG-enhanced transcranial magnetic stimulation (eTMS) as an adjunct to standard-of-care therapies for chronic trauma and stressor related disorders (TSRD) among US military veterans.

The main questions the study aims to answer are:

Is it safe to provide 30 sessions of eTMS for veterans with chronic TSRD?
Is it feasible to provide 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD?
Does health-related quality of life improve among veterans after 30 sessions of eTMS as an adjunct to standard-of-care therapies for chronic TSRD?

Participants will undergo 30 sessions of eTMS as an adjunct to standard-of-care therapies for veterans with chronic TSRD, weekly reassessment during treatment, and intermittent follow-up for 36 weeks post-enrollment.

Enrollment

30 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Positive identification as a Veteran per discharge paperwork (DD-214, DD-215, NGB-22, NGB-22A) and photo ID, or Veterans Health Administration Veteran Health Identification Card (VHIC)
Presence of deployment-related stressful events (as defined by the Deployment Risk & Resilience Inventory-2, DRRI-2)
Trauma event(s) (defined on the Life Experiences Checklist for DSM-5, LEC-5)
Presence of 6 months or more of 6 or more "moderate" or worse symptoms from any of the five categories associated with stress disorders as operationalized on the PTSD Checklist for DSM-5 (PCL-5; intrusion, altered mood and cognitions, dissociation, avoidance, and arousal).
Informed consent for study participation, off label-eTMS, and data use
Enrollment in addiction services, if meets standard addiction treatment criteria
Enrollment in opioid reduction services, if dependent on opioids and morphine equivalent daily dose exceeds 50 mg (50 morphine equivalent daily dose, MEDD)
Agreement to limit daily alcoholic beverage consumption to no more than 2 servings
Signed pain contract, if MEDD >= 80, per State of Ohio prescribing guidelines

Exclusion criteria

Uncontrolled medical, psychological or neurological conditions including, but not limited to:
Uncontrolled psychosis or mania
Uncontrolled seizure disorder or EEG abnormalities that indicate risk of seizure, i.e., epileptiform discharges during the EEG recording
Uncontrolled cardiac, pulmonary, or endocrine disorder (e.g., diabetes)
Acute pain or illness
Active, untreated addiction to prescription drugs, alcohol or illicit substances (not including cannabis or derivatives, which are available in many states under medical prescription or for recreational use)
Clinically significant medical condition or abnormality that in the Investigator's judgment might pose a potential safety risk to the subject or limit the interpretation of the trial results
Pregnant, or female unwilling to use effective birth control during the course of the trial (unless cleared for participation by obstetrician/gynecologist)
Absolute contraindications to TMS: Presence of aneurysm clips or coils, cochlear or ocular implant, cortical epidural stimulator, deep brain stimulator, pacemaker or defibrillator, retained intracranial metal foreign body (bullets, shrapnel - excluding titanium and oral implants), steel stents or shunts, active vagal nerve stimulator, ventriculoperitoneal (VP) shunt.
Prior TMS treatment
Unwilling or unable to adhere to the study treatment, data collection schedule, or study procedures