Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD)
- Conditions
- Trauma and Stressor Related Disorders
- Interventions
- Device: Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS)
- Registration Number
- NCT05835414
- Lead Sponsor
- Marcia Bockbrader, MD PhD
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adjunctive eTMS treatment (no delay) Adjunctive, midline prefrontal, lower intensity, shorter session, EEG-enhanced, repetitive transcranial magnetic stimulation (eTMS) 6 weeks (30 sessions) of daily eTMS as an adjunct to standard of care TSRD treatment
- Primary Outcome Measures
Name Time Method Number of participants with device-related serious adverse events 6 weeks To address safety of the procedure, the study investigators will report number of participants (of 30 initial cohort) with expected, device-related serious adverse events (SAE's) or unexpected, device-related SAE's during treatment
Rate of participants completing 80% of scheduled visits 6 weeks To assess feasibility of the procedure, the study investigators will report the rate of participants (for initial cohort of 30) completing \>= 80% of the 30 scheduled eTMS sessions
- Secondary Outcome Measures
Name Time Method Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS) 6 weeks To assess efficacy of the procedure to improve health related quality of life, the study investigators will report the mean change from baseline to week 6 in mental component score (MCS) on Veterans RAND 36-item health survey (VR-36) for participants (in initial cohort of 30) who completed \>=80% of eTMS sessions
Trial Locations
- Locations (1)
BEP Medical Group LLC
🇺🇸Columbus, Ohio, United States