A Feasibility Study of a Sphenopalatine Ganglion (SPG) Block for Post Traumatic Stress Disorder (PTSD)
概览
- 阶段
- 早期 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Post Traumatic Stress Disorder
- 发起方
- New York State Psychiatric Institute
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- tolerability: number of adverse events
- 状态
- 已完成
- 最后更新
- 2年前
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.
研究者
Diana Martinez
Clinical professor in Psychiatry
New York State Psychiatric Institute
入排标准
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
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