跳至主要内容
临床试验/NCT02510729
NCT02510729已完成不适用

Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients

Danish Headache Center1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年7月最近更新:
适应症
干预措施

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

入选标准

  • Chronic cluster patients

排除标准

  • 未提供

研究组 & 干预措施

SPG neurostimulation

Active Comparator

Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz

干预措施: Neurostimulation (Device)

Sham Stimulation

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Song Guo

MD, PhD student

Danish Headache Center

研究点 (1)

Loading locations...

相似试验