Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- changes in the visual analogue scale
研究概览
简要总结
Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin)
详细描述
Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy.
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, Outcomes Assessor)
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
- •any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment
排除标准
- •patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia,
- •higher brain dysfunction,
- •migraine headache,
- •brain cancer or metastasis and
- •those known to have epilepsy
研究组 & 干预措施
active tDCS
tDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days
干预措施: transcranial dirrect current brain stimuation (Device)
sham tDCS
tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds
干预措施: transcranial dirrect current brain stimuation (Device)
结局指标
主要结局
changes in the visual analogue scale
时间窗: 0 (prestimulation), on the 5th day, 15th days and one month after the last session
patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable
次要结局
- changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)(0 (prestimulation),on the 5th day, 15th days and one month after the last session)
研究者
Shereen Mamdouh
Associate professor
Assiut University