Effect of Motor Cortex Versus Insula Cortical Targets Stimulation Using Concentric Electrode Transcranial Direct Current Stimulation on Chronic Post-mastectomy Pain; a Randomized Sham Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- chronic postmastectomy pain relief
研究概览
简要总结
This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation over the primary motor cortex versus insular cortical targets in post mastectomy neuropathic pain.
详细描述
eighty patients within age group 18-65 years old with post mastectomy neuropathic pain that are resistant to medical treatment in the form of tramadol hydrochloride 100 mg twice daily, pregabalin 75 mg twice daily and Amitriptyline 25 mg once daily for at least two months or associated with significant adverse effect from medication will be involved in this study.
twenty patients will be randomly allocated into one of the study designed groups using serially numbered opaque closed envelopes. Each patient will be placed in the appropriate group after opening the corresponding sealed envelope. The patient will receive one of the following interventions either:
- active tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day),
- sham 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 ,
- active tDCS (2mA) targeting the insula of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day),
- sham tDCS over the insula in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
serially numbered opaque closed envelopes. Each patient will be placed in the appropriate group after opening the corresponding sealed envelope
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eighty patients within age group 18-65 years old with post mastectomy neuropathic pain that are resistant to medical treatment in the form of tramadol hydrochloride 100 mg twice daily, pregabalin 75 mg twice daily and Amitriptyline 25 mg once daily for at least two months or associated with significant adverse effect from medication will be involved in this study.
排除标准
- •We will exclude patients with intracranial metallic devices or with pacemakers or any other device. We also exclude those with extensive myocardial ischemia and those known to have epilepsy
研究组 & 干预措施
group 1: active primary motor cortex stimulation
active tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day)
干预措施: Transcranial direct current stimulation (Device)
group 2 : sham primary motor cortex stimulation
sham 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 direct current stimulation (Device)
group 3 : active insula stimulation
active tDCS (2 mA) targeting the insula of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day)
干预措施: Transcranial direct current stimulation (Device)
group 4 : sham insula stimulation
sham tDCS over the insula 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 direct current stimulation (Device)
结局指标
主要结局
chronic postmastectomy pain relief
时间窗: VAS monitoring one month later
pain relief on the VAS 1 month later
chronic postmastectomy pain relief
时间窗: VAS monitoring after 5th session
pain relief on the VAS after the 5th session
chronic postmastectomy pain relief
时间窗: VAS monitoring after 15 days
pain relief on the VAS after 15 days
次要结局
- VDS, LANSS and depression symptoms by HAM-D(VDS, LANSS and depression symptoms by HAM-D after one month)
- VDS, LANSS and depression symptoms by HAM-D(VDS, LANSS and depression symptoms by HAM-D after 5th session)
- VDS, LANSS and depression symptoms by HAM-D(VDS, LANSS and depression symptoms by HAM-D after 15 days)
研究者
Mohannad Ahmed Mohamed
Principal Investigator
South Egypt Cancer Institute