Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient reported pain score on SMS text EMA system
研究概览
简要总结
The purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain.
详细描述
The purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain. Participants will be screened by study staff for contraindications to TMS treatment. TMS will be delivered use the MagVenture TMS machine. TMS will be delivered during 15 minutes per session, 3 sessions each day, for 3 days. A custom developed SMS text EMA system will be used to gather daily data on pain and functioning in study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with chronic scrotal pain lasting for 6 or more months.
- •Pain must be present 3 or more days of the week.
排除标准
- •No new pain medications within the last 30 days.
研究组 & 干预措施
Open label
Open label study. Participants will be screened by study staff for contraindications to TMS treatment. TMS will be delivered use the MagVenture TMS machine.
干预措施: Transcranial magnetic stimulation (Other)
结局指标
主要结局
Patient reported pain score on SMS text EMA system
时间窗: baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months)
A custom developed SMS text EMA system will be used to gather daily data on pain
次要结局
- Patient reported post procedure quality of life as measured on an SMS text EMA system(baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months))
- Progression to other treatments(Within 6 months after completion)