Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.
详细描述
This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.
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)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients with cancer who developed neuropathic pain in the affected area secondary the surgical procedure, chemotherapy or radiation that meet the following Inclusion/
排除标准
- •Inclusion Criteria:
- •Pain on the side of the lesion
- •Spontaneous pain with a score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10
- •Must present the following symptoms and signs:
- •Continuous burning, shooting, or lancinating pain.
- •Presence of hyperesthesia
- •Presence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
- •Exclusion Criteria:
- •Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
- •Pain/painful conditions unrelated to the cancer or related treatment
- •Pregnancy
- •History of seizures/epilepsy
- •Any implanted devices (e.g. a cardio stimulator, etc)
- •Active illegal drug/alcohol abuse
- •Unable to follow directions or complete tools in English
研究组 & 干预措施
real tDCS stimulation
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
干预措施: non-invasive transcranial direct current stimulation (tDCS) (Device)
Sham tDCS
sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
干预措施: non-invasive transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Pain Intensity
时间窗: Assessed at baseline and post tDCS stimulation day 5
Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure "Pain intensity" assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2).
次要结局
未报告次要终点