Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in Epigenetic Aging at 180 days
研究概览
简要总结
The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.
详细描述
The primary objective of this study is to assess the impact of a combined protocol of subanesthetic ketamine infusions (SKI) and bilateral cervical sympathetic blocks (CSB) on aging, as measured by the GrimAge epigenetic clock.
The secondary objective of this study is to assess the impact of this treatment paradigm on PTSD and mental health, as measured over a 6 month time period using the following questionnaires: Post-traumatic Stress Disorder Checklist (PCL-5), Patient Health Questionnaire 9 (PHQ-9), Depressive Symptom Index-Suicidality Subscale (DSI-SS), Generalized Anxiety Disorder 7-item (GAD-7), and Neurobehavioral Symptom Inventory (NSI).
The tertiary objectives of the study are to investigate if PTSD is associated with significantly reduced free testosterone levels and increased C-reactive protein (CRP) levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recruited from SOF with an active duty history of at least 5 years.
- •Subjects may be in active duty or retired, male and female, between the ages of 40 and 60 years old.
- •The participants must have a confirmed diagnosis of PTSD, identified by Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) scores higher than
- •The participants must have been on a stable pharmacological or psychotherapeutic therapy for at least three months (if applicable), and continue this treatment throughout the duration of the study.
- •They must be able and willing to consent for the study. Individuals who are able to become pregnant must adhere to a medically accepted method of contraception (eg. hormonal birth control, barrier birth control, intrauterine device, abstinence).
排除标准
- •Existing Horner syndrome;
- •Allergy to local anesthetics or contrast;
- •Previous history of stellate ganglion block with psychosis;
- •Admission to in-patient psychiatric facility within last 3 months;
- •History of moderate of severe TBI;
- •Currently pregnant or breastfeeding;
- •Current substance use disorder, or test positive for 1 or more illegal or controlled drugs on the initial urine drug screen, such as cocaine, marijuana, amphetamines, opioids, benzodiazepines, amongst others;
- •Previous behavioral health diagnoses (bipolar I, psychosis, etc);
- •Currently undergoing exposure therapy.
结局指标
主要结局
Change from baseline in Epigenetic Aging at 180 days
时间窗: day 180
GrimAge epigenetic clock tool to assess DNA methylation
Change from baseline in Epigenetic Aging at 90 days
时间窗: day 90
GrimAge epigenetic clock tool to assess DNA methylation
Change from baseline in Epigenetic Aging at 15 days
时间窗: day 15
GrimAge epigenetic clock tool to assess DNA methylation
次要结局
- Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 180 days(day 180)
- Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 15 days(day 15)
- Change from baseline in Post-Traumatic Stress Disorder (PTSD) symptoms at 90 days(day 90)
- Change from baseline in Depression at 180 days(day 180)
- Change from baseline in Suicidal Ideation at 180 days(day 180)
- Change from baseline in Anxiety at 90 days(day 90)
- Change from baseline in Suicidal Ideation at 90 days(day 90)
- Change from baseline in Post-Concussion Symptom Severity at 15 days(day 15)
- Change from baseline in Post-Concussion Symptom Severity at 90 days(day 90)
- Change from baseline in Post-Concussion Symptom Severity at 180 days(day 180)
- Change from baseline in C-reactive protein (CRP) levels at 180 days(day 180)
- Change from baseline in Depression at 15 days(day 15)
- Change from baseline in Depression at 90 days(day 90)
- Change from baseline in Free testosterone levels at 180 days(day 180)
- Change from baseline in Suicidal Ideation at 15 days(day 15)
- Change from baseline in Anxiety at 15 days(day 15)
- Change from baseline in Anxiety at 180 days(day 180)
- Change from baseline in Free testosterone levels at 90 days(day 90)
- Change from baseline in Free testosterone levels at 15 days(day 15)
- Change from baseline in C-reactive protein (CRP) levels at 15 days(day 15)
- Change from baseline in C-reactive protein (CRP) levels at 90 days(day 90)
研究者
Eugene Lipov
Principal Investigator
Stella Center