A Feasibility Study of a Sphenopalatine Ganglion (SPG) Block for Post Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- tolerability: number of adverse events
研究概览
简要总结
Some patients with Post Traumatic Stress Disorder (PTSD) respond only partially to medication. This study is a pilot study investigating whether blocking the SPG helps reduce the symptoms of PTSD. This study does not involve treatment with medications. It is a proof of principal study.
详细描述
The sphenopalatine ganglion (SPG) is a collection of neurons involved in autonomic regulation (which refers to bodily processes that are automatic like heart rate and blood pressure). Blocking the SPG is used to treat disorders, such as migraines or cluster headaches (short, severe headaches that occur together). The procedure will be performed by a doctor who specializes in ear, nose throat surgery. The block consists of the injection of a numbing agent (similar to the type used by dentists) to the SPG. After the SPG block, we will follow patients for 8 weeks to see how they feel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a principal diagnosis of PTSD on stable dose of psychiatric medication or in stable psychotherapy for at least 3 months, who experience residual symptoms.
- •Participants who understand all study procedures and can undergo informed consent
排除标准
- •Participants with a medical disorder, for whom study participation could be deleterious (neurologic, cardiac, renal or infectious disease)
- •Pregnant or breast feeding participants
- •Participants who are on an anticoagulant, such as warfarin, or otherwise have a medical condition that increases bleeding risk
研究组 & 干预措施
Active SPG block
The block will be performed using a topical aerosolized nasal spray followed by the administration of a local anesthetic.
干预措施: Sphenopalatine ganglion block (Other)
结局指标
主要结局
tolerability: number of adverse events
时间窗: 8 weeks
tolerability: number of adverse events
feasibility: number of participants completing the 8-week study
时间窗: 8 weeks
feasibility: number of participants completing the 8-week study
次要结局
未报告次要终点
研究者
Diana Martinez
Clinical professor in Psychiatry
New York State Psychiatric Institute