electroencephalogram (eeg) enhanced transcranial magnetic stimulation (etms) for chronic trauma and stressor-related disorders (tsrd)

Conditions: Trauma and Stressor Related Disorders

Summary: 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.


Eligibility criteria:
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

Keywords: transcranial magnetic stimulation chronic trauma and stressor related disorders veterans rand 36-item health survey (vr-36) health related quality of life eeg alpha rhythms