Trauma and Stressor Related Disorders Clinical Trial
— ETMS4StressOfficial title:
Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | BEP Medical Group LLC | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Marcia Bockbrader, MD PhD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with device-related serious adverse events | 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 | 6 weeks | |
Primary | Rate of participants completing 80% of scheduled visits | 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 | 6 weeks | |
Secondary | Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS) | 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 | 6 weeks |
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