EEG-enhanced transcranial magnetic stimulation for veterans with trauma-related disorders
Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)
This study is testing a new brain treatment called eTMS to see if it can help veterans with trauma-related disorders feel better when combined with their usual therapies.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | BEP Medical Group, LLC Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05835414 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety, feasibility, and preliminary efficacy of EEG-enhanced transcranial magnetic stimulation (eTMS) as an adjunct to standard therapies for chronic trauma and stressor-related disorders (TSRD) in US military veterans. Participants will receive 30 sessions of eTMS, with weekly assessments during treatment and follow-ups for 36 weeks post-enrollment. The study will measure improvements in health-related quality of life using the Veterans RAND 36-item health survey (VR-36).
Who should consider this trial
Good fit: Ideal candidates for this study are US military veterans who have experienced deployment-related stressful events and exhibit moderate to severe symptoms of stress disorders.
Not a fit: Patients who do not meet the criteria for chronic trauma and stressor-related disorders or those who are not veterans may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for veterans suffering from chronic trauma and stressor-related disorders.
How similar studies have performed: Other studies have shown promise with transcranial magnetic stimulation for various mental health conditions, suggesting potential for success with this novel EEG-enhanced approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- BEP Medical Group LLC — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Marcia A Bockbrader, MD, PhD
- Email: dr.marcie@bepmedicalgroup.com
- Phone: 614-670-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.