Electroencephalogram (EEG) Enhanced Transcranial Magnetic Stimulation (eTMS) for Chronic Trauma and Stressor-Related Disorders (TSRD) (ETMS for Stress)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants with device-related serious adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with device-related serious adverse events
时间窗: 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
时间窗: 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
次要结局
- Mean change in Veterans RAND 36-item health survey (VR-36) mental component scores (MCS)(6 weeks)
研究者
Marcia Bockbrader, MD PhD
Principal Investigator
BEP Medical Group, LLC