Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS4Stress)
Trauma and Stressor Related Disorders
About this trial
This is an interventional treatment trial for Trauma and Stressor Related Disorders focused on measuring 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
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
Sites / Locations
- BEP Medical Group LLCRecruiting
Arms of the Study
Arm 1
Experimental
Adjunctive eTMS treatment (no delay)
6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment