Closed Loop Vagal Nerve Stimulation in Patients With Posttraumatic Stress Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Level of Interleukin-6 (IL6)
研究概览
简要总结
The tasks of the project are to map the potency and kinetics of the neurologic, autonomic peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham treatment, at baseline and in response to stressful traumatic scripts related to personal traumatic events, as well as a series of other stressors.
详细描述
The purpose of this project is to develop the fundamental physiological understanding of feedback controlled vagal nerve stimulation (VNS) using positron emission tomography (PET) brain imaging and blood biomarker measurement with stress in healthy individuals and individuals with PTSD. Healthy human subjects with a history of psychological trauma but without the diagnosis of a psychiatric disorder (Phase 1), and human subjects with a history of PTSD (Phase 2), undergo PET imaging of the brain in conjunction with VNS or a sham treatment during exposure to neutral scripts and scripts of personal traumatic events. Blood is drawn simultaneously for measurement of a variety of stress responsive biomarkers, including inflammatory markers and neurohormones. A second PET scan with biomarkers assesses the delayed effects of VNS. On two other days subjects undergo exposure to random stressors with VNS or sham in conjunction with measurement of stress biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Do not meet criteria for post traumatic stress disorder (PTSD) or other major mental disorder as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5 SCID) interview for PTSD
- •Have a history of psychological trauma as defined by DSM-
- •Meet criteria for PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD.
排除标准
- •Positive pregnancy test
- •Meningitis
- •Traumatic brain injury
- •Neurological disorder or organic mental disorder
- •History of loss of consciousness greater than one minute
- •Alcohol abuse or substance abuse or dependence based on the SCID within the past 12 months
- •Positive toxicology screen
- •Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
- •A history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
- •Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (complete blood count (CBC), blood urea nitrogen (BUN), creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG)
- •Active implantable device (i.e. pacemaker)
- •Carotid atherosclerosis
- •Cervical vagotomy
研究组 & 干预措施
Vagal Nerve Stimulation
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
干预措施: GammaCore/electroCore non-invasive VNS device (Device)
Vagal Nerve Stimulation
Participants randomized to this arm will receive stimulation of the vagus nerve in conjunction with stress exposure.
干预措施: O-15 water (Drug)
Sham Stimulation
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
干预措施: Sham gammaCore/electroCore (Device)
Sham Stimulation
Participants randomized to this arm will receive sham stimulation of the vagus nerve in conjunction with stress exposure.
干预措施: O-15 water (Drug)
结局指标
主要结局
Level of Interleukin-6 (IL6)
时间窗: Baseline, Post Stress Testing (Up to 4 Hours)
IL6 level will be collected via blood draw. Change is defined as the difference in IL6 level from baseline to post emotional stress testing.
次要结局
- Level of Tryptophan(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Kynurenine(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Kynurenic Acid(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of 3-3 Hydroxykynurenine(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Anthranilic Acid(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Tumor Necrosis Factor (TNF)-Alpha(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-10 (IL10)(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-12p70 (IL12p70)(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-12p (IL12p)(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-13 (IL13)(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interferon-Gamma(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-1 Beta(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-2 (IL2)(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-4 (IL4)(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Interleukin-8 (IL8)(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Macrophage Migration Inhibitory Factor(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of High-Mobility Group Protein B1(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Adrenocorticotropic Hormone(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Cortisol(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Epinephrine(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Dopamine(Baseline, Post Stress Testing (Up to 4 Hours))
- Level of Norepinephrine(Baseline, Post Stress Testing (Up to 4 Hours))
研究者
J. Douglas Bremner, MD
Professor
Emory University