Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Pain
研究概览
简要总结
The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single, blinding of participant
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70
- •Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
- •Average pain level reported on Numerical Rating Scale meets entry criteria
- •Ability to perform the experimental task and procedures.
排除标准
- •MRI contraindication (metal implants or devices, claustrophobia)
- •TMS Contraindication (eg metal implant or devices near the site of stimulation)
- •History of epilepsy
- •History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
- •Neurologic illness that would interfere with brain integrity
- •Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
- •Currently pregnant or planning to become pregnant.
- •On going legal action or disability claim.
研究组 & 干预措施
Sham Treatment
Participants will receive active TMS in a non-target area once daily for two days
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
Active Treatment
Participants will receive active TMS in the target area once daily for two days
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
结局指标
主要结局
Change in Pain
时间窗: 1 week follow-up compared to baseline
Decrease in CRPS-related Pain Ratings
Duration of Pain Relief
时间窗: Duration from last treatment until pain returns - up to an estimate of 6 months
Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks
次要结局
- Change in Pain-related Symptomology(Duration from last treatment until pain returns - up to an estimate of 6 months)
研究者
Sean Mackey
Chief, Division of Pain Medicine
Stanford University