Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
研究概览
简要总结
This is an open-label safety pilot study of the Electroencephalogram (EEG) Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 30 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 10 in-office visits that take place over 21 total days. Two eTMS treatment sessions are administered during each office visit.
详细描述
eTMS-PTSD-001 is an open-label safety pilot study with a recruitment goal of 30 subjects, with 26 completers. The Study is intended to evaluate the safety aspects of eTMS in the target population. A maximum of 400 individuals will be screened in order to achieve the recruitment goal. The total number of days from the first participant enrolled to the last enrolled participant treated will be approximately 7 months.
Participants will be either Veterans or First Responders (e.g., emergency medical service provider, firefighter, or any other emergency response personnel), between 22-65 years of age. Participants may be male or female of any racial/ethnic background who meet the eligibility criteria. Participants will be recruited from the general public, and from veterans and first responder organizations.
The primary outcome for the Study will be the incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of adverse events during the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to consent to participate in the study via signed Informed Consent
- •Age 22 - 65 years
- •Provisional diagnosis of PTSD
- •Positive identification as either a Veteran, or First Responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel)
排除标准
- •Uncontrolled medical, psychological or neurological condition
- •Pregnant, or female unwilling to use effective birth control during the course of the trial
- •Metal objects implanted in the head
- •Past exposure to metal fragments or other metal sources in the head and neck
- •Current participation in any interventional research protocol
- •History of any type of Electroconvulsive Therapy (ECT) or TMS
- •History of stroke or intracranial lesion, or increased intracranial pressure
- •History or epilepsy or seizure
- •Family history of epilepsy or seizure in 1st degree relative.
结局指标
主要结局
Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
时间窗: Baseline and Final Measure, between 10-21 Days
Number - Number of adverse events reported. Note that each participant may have had more than one adverse event (AE). Severity - Number of adverse events that were mild, moderate, or severe. Relatedness - Number of adverse events that were not related, suspected, or definitely related to treatment. Type - Number of adverse events that were or were not Serious Adverse Events (SAEs). Subsequent treatment/intervention required - Number of adverse events that did or did not require subsequent treatment/intervention. Number of participants reporting at least one AE
次要结局
- Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)(Baseline and Final Measure, between 10-21 Days)