Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of cluster-like attacks and cephalic autonomic symptoms
研究概览
简要总结
We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.
详细描述
We conducted a double-blind, randomized, sham-controlled, crossover study to investigate cluster attack induction following LF (20 Hz and 0.2-2.1 amplitude) and sham (amplitude = 0) stimulation in 20 CH patients with implanted SPG neurostimulator. In addition, we measured plasma concentrations of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal peptide (VIP), as markers for parasympathetic activation before, during and after SPG stimulation. We also investigated if LF SPG stimulation induces changes in cardiac autonomic regulation and whether any attacks induced by SPG stimulation are associated with such changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic cluster patients
排除标准
- 未提供
研究组 & 干预措施
SPG neurostimulation
Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
干预措施: Neurostimulation (Device)
Sham Stimulation
Sham stimulation with amplitude=0
干预措施: Sham stimulation (Device)
结局指标
主要结局
Incidence of cluster-like attacks and cephalic autonomic symptoms
时间窗: 0-60 min
Difference in incidence of cluster-like attacks and cephalic autonomic symptoms between LF and sham stimulation.
次要结局
- Plasma concentrations of PACAP38 and VIP(0-60 min)
- Mean arterial blood pressure and heart rate(0-60 min)
- Cardiac autonomic regulation (HRV)(0-60 min)
- Mechanical detection and pain thresholds(0-60 min)
- Headache intensity(0-60 min)
研究者
Song Guo
MD, PhD student
Danish Headache Center