Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Pain intensity measurement
研究概览
简要总结
Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.
详细描述
This project introduces a new research question that incorporates virtual reality mirror therapy into an established treatment protocol of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain relief. Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.
Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS. The efficacy of using both techniques in neuropathic pain treatment is unknown. The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy on: 1) daily pain intensity (i.e. analgesic efficacy); 2) other components of pain and the quality of life; 3) brain activity.
It will be the first to provide insight into the efficacy of using together both non-invasive technics of cortical neuromodulation to alleviate pain.
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
- Double (Participant, Investigator)
盲法说明
The (motor) task performed by the patient during the sham control mirror therapy session is identical to that performed in active mirror therapy. The only difference is that in sham mirror therapy there is no optical illusion of movement of the affected hand.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms typical of neuropathic pain
- •Refractory to drug therapies
- •Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least
- •Having right to health benefits
排除标准
- •Ferromagnetic components and implanted microprocessors (i.e. cochlear implants)
- •Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment.
- •Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).
研究组 & 干预措施
rTMS active and active mirror-based therapy using virtual reality
The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and active mirror-based therapy using virtual reality.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Other)
rTMS active and active mirror-based therapy using virtual reality
The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and active mirror-based therapy using virtual reality.
干预措施: Mirror therapy using virtual reality (Other)
rTMS active and sham mirror-based therapy using virtual reality
The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and sham mirror-based therapy using virtual reality.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Other)
rTMS active and sham mirror-based therapy using virtual reality
The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and sham mirror-based therapy using virtual reality.
干预措施: Mirror therapy using sham mirror (Other)
结局指标
主要结局
Pain intensity measurement
时间窗: Week 9
Averages of the daily visual analogue scale scores (min no pain max pain imaginable) measured during the first week (Week 1) and that measured during the week following the last session (week 9)
次要结局
- Spontaneous brain activity(week 12)
- Adverse events(Week 3, 5, 7, 9,12)
- Quality of life after treatment(week 12)
- neuropathic dimension(Week 3, 5, 7, 9,12)