NL-OMON44572已完成3 期
Stimulation of the sphenopalatine ganglion with the ATI Neurostimulation system for cluster headache treatment - SPG stimulation for cluster headache treatment
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-18-65 years old.
- •-classified with chronic cluster headache ICHD-3 criteria 3.1.2
- •-reported headache frequentie of 10 weekly
- •-Patient reported dissatisfaction with current headache treatments.
- •-Patient was able to distinguish cluster headaches from other headaches.
- •-knowledge dutch language
排除标准
- •-Patient had a change in type or dosage of preventive headache medications within one month of enrollment.
- •-Women of childbearing age who were pregnant, nursing, or not using contraception.
- •-Patient had undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site within the last four months.
- •-Patient had been treated with radiation to the facial region within the last six months.
- •-Patient had been diagnosed with any major infectious processes including osteomyelitis or primary or secondary malignancies of the face that were active or required treatment in the past six months.
- •Patient had another significant pain problem that might confound the study assessments in the opinion of the investigator.
研究者
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