Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain relief
研究概览
简要总结
The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.
详细描述
This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).
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)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •Speak and understand English.
排除标准
- •Pregnancy
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Previous neurologic, musculoskeletal or mental illnesses
- •Lack of ability to cooperate
- •History of chronic pain or current acute pain
- •Previous experience with rTMS
- •Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
- •Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
研究组 & 干预措施
Real treatment group
Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction.
The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
干预措施: Repetitive trancranial magnetic stimulation (rTMS) group (Device)
Sham treatment group
Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation
干预措施: Sham group (Device)
结局指标
主要结局
Pain relief
时间窗: Change from baseline at 2 weeks
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
次要结局
- Muscle soreness(Change from baseline at 2 weeks)
- Patient-rated Tennis Elbow Evaluation(Change from baseline at 2 weeks)
- Attention network test(Change from baseline at 2 weeks)
- Pressure pain thresholds(Change from baseline at 2 weeks)
- Cuff pressure algometry(Change from baseline at 2 weeks)
- EEG recordings(Change from baseline at 1 weeks)
研究者
Enrico De Martino
Medical Doctor
Aalborg University