HIRREM for Mitigation of PTSD Symptoms in Military Personnel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in PCL-M Score From Baseline to 12 Days
研究概览
简要总结
The purpose of this study is to evaluate the effects associated with the use of in-office High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) for participants with symptoms of military-related traumatic stress. This is a single site, non-randomized, open label pilot study. Outcome measures collected before, and after the intervention evaluate effects on self-reported symptoms, autonomic cardiovascular regulation, functional measures, blood and saliva biomarkers of stress and inflammation, and network connectivity on whole brain, rest MRI testing. Self-reported symptom outcomes will also be collected remotely at 1, 3, and 6 months after completion of intervention. The study will assess feasibility in this cohort, focused on the Special Operations community, will provide estimates of effect size, and durability of symptom changes, while providing important pilot data for future proposals and investigations.
详细描述
This will be an open label, single site, pilot, clinical research study. Up to 40 active duty military personnel, or recent Veterans, age 18 or older, who have been diagnosed with PTSD, have received treatment for, are referred by military medical personnel for, or have active symptoms of military-related traumatic stress, with or without mild TBI, will be recruited to receive up to 24 HIRREM sessions over 2 weeks. For those who self-refer, and do not have a prior diagnosis or treatment for PTSD, active symptoms will be identified by a screening PCL-M score of 50 or greater. Recruitment of 40 participants will allow us to achieve the goal of 36 participants to complete the intervention, allowing for the possibility of dropouts. The primary outcome will be differential change in the PCL-M from baseline to completion of HIRREM sessions. Secondary measures include the Insomnia Severity Index (ISI), the Center for Epidemiological Studies Depression Scale (CES-D), an anxiety measure (GAD-7), a quality of life measure (EQ-5D), an autonomic symptom measure (Compass 31), and a daily sleep diary, as well as physiological measures including heart rate (HR), and blood pressure (BP), with calculation of heart rate variability measures (HRV), and baroreflex sensitivity (BRS). Functional measures will include reaction time (drop-stick paradigm), and grip strength (hydraulic dynamometer), and analysis of brain patterns. If there is a history of TBI, a Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will be added. There will be pre- and post-intervention data collection for all measures (baseline, V1, and at completion of HIRREM sessions, V2). Self-report measures will also be repeated by phone at 1, 3, and 6 months after completion of sessions (V3, V4, and V5 respectively). The online sleep diary will be maintained from V1 until V3. A brainwave assessment will be obtained at V1.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active duty military personnel, or recent veterans (Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn), men and women, with a diagnosis of PTSD, or active symptoms suggesting PTSD as identified by a screening PCL-M score of 50 or greater, with or without traumatic brain injury (TBI), are eligible to participate in the study.
排除标准
- •Unable, unwilling, or incompetent to provide informed consent
- •Physically unable to come to the study visits, or to sit in a chair for several hours
- •Known seizure disorder
- •Severe hearing impairment (because the subject will be using ear buds during HIRREM)
- •Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone
- •Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
- •Lack of internet or smart phone access (will maintain remote access daily sleep diary through 1 month post-HIRREM visit)
结局指标
主要结局
Change in PCL-M Score From Baseline to 12 Days
时间窗: Data is collected at baseline and immediately following completion of the HIRREM intervention (up to 12 days later)
The PTSD Checklist (PCL) - Military (M) is a symptom checklist to measure stress severity due to a traumatic experience in military settings. The PCL-M measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) of PTSD symptoms based on traumatic life experience. Seventeen items are rated on a Likert scale from 1 (not at all) to 5 (extremely), with a total score ranging from 17 to 85. Higher scores suggest more PTSD symptoms. Primary outcome for this pilot study will be change in PCL-M score from baseline to the immediate post-intervention in-person data collection at the completion of the HIRREM intervention (up to 12 days later).
次要结局
- Salivary Biomarker Cortisol for Stress From Baseline to 12 Days(Salivary biomarker for stress will be obtained at baseline and immediately following completion of the intervention (up to 12 days))
- Salivary Biomarker for Stress From Baseline to 12 Days(Salivary biomarker Alpha-Amylase for stress will be obtained at baseline and immediately following completion of the intervention (up to 12 days))
- Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) Score From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in EQ-5D Score From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Heart Rate Variability Measure of SDNN From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Generalized Anxiety Disorder-7 (GAD-7) Score From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Baroreflex Sensitivity Sequence Down From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Grip Strength From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Insomnia Severity Index (ISI) Score From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in C-reactive Protein for Stress and Inflammation Score From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Baroreflex Sensitivity HF Alpha From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Baroreflex Sensitivity Sequence Up From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Baroreflex Sensitivity Sequence All From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Drop Stick Reaction Time From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Epigenetic Markers From Baseline to 12 Days(Blood for epigenetic markers will be obtained at baseline and immediately following completion of the intervention (up to 12 days))
- Change in Sleep Latency Score From Baseline to 42 Days(Sleep diary data will be collected daily via online access from baseline to a month following completion of intervention (up to 42 days))
- Change in Functional MRI From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))
- Change in Blood Biomarkers for Stress and Inflammation Score From Baseline to 12 Days(Data is collected at baseline and immediately following completion of the intervention (up to 12 days later))