Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy: a Randomized Cross- Over Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- visual analogue pain scale (VAS pain scale)
研究概览
简要总结
Laboratory studies have shown that prolonged continuous theta burst stimulation (pcTBS) provides better pain relief than 10 Hz repetitive transcranial magnetic stimulation (rTMS), with a shorter stimulation time, making it more practical for clinical use. Chemotherapy-induced peripheral neuropathy often causes neuropathic pain in cancer patients. The aims of this study are:
- To compare the effects of pcTBS and 20 Hz rTMS on chemotherapy-induced peripheral neuropathy;
- To compare the effects of pcTBS applied to the primary motor cortex versus the dorsolateral prefrontal cortex on neuropathic pain as well as depression and anxiety.
详细描述
**Phase 1:** Investigators will recruit 20 breast cancer patients who have chemotherapy-induced peripheral neuropathy. They will be randomly divided into two groups.
- Group 1 will first receive pcTBS. After an 8-week break, they will then receive 20 Hz rTMS.
- Group 2 will receive the treatments in the opposite order.
Each treatment lasts for 5 consecutive days. Before and after each treatment, patients will be assessed using:
- A pain visual analog scale (to measure pain levels)
- A Neuropathic Pain Symptom Inventory (The scale ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain)
• * A Depression Anxiety Stress Scale 21 (The scale ranges from 0-63, with a higher scores mean a worse outcome)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer patients aged between 18- and 80-years-old with CIPN
- •history of receiving chemotherapy including taxane-based neurotoxic agents
- •with neuropathic pain, score≥3 in a 0-10 VAS pain scale.
- •with fair cognition and can cooperate to evaluate pain severity.
- •neither at end-stage cancer nor at the estimated survival time less than 6 months.
排除标准
- •brain tumor or history of epilepsy
- •intracranial metallic devices, artificial cochleae, pacemakers, or any other metal device
- •recent myocardial ischemia or unstable angina
- •severe cognitive dysfunction or pregnancy
- •injuries or fractures in the part of neuropathic pain
结局指标
主要结局
visual analogue pain scale (VAS pain scale)
时间窗: baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up
visual analogue pain scale (VAS) range from 0-100, with a higher score inducating more pain
次要结局
- Depression Anxiety Stress Scale 21(baseline and after completion the intervention and at 4 weeks follow-up)
- pressure pain threshold test(baseline and after completion the intervention and at 4 weeks follow-up)
- Neuropathic Pain Symptom Inventory(baseline and after completion the intervention and at 4 weeks follow-up)