NCT07293780招募中不适用
The Effect of Transcranial Magnetic Stimulation Applied to the Primary Motor Cortex and Anterior Cingulate Cortex on Refractory Neuropathic Pain in Spinal Cord Injury
Ankara Etlik City Hospital4 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年12月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- visual analog scale
研究概览
简要总结
The aim of this study is to evaluate the efficacy of rTMS targeting the anterior cingulate cortex, another stimulation site that may be effective in the treatment of neuropathic pain, and to compare it with motor cortex stimulation.
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
- Single (Participant)
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
- •Patients for whom at least 12 months have passed since the date of the event
- •Patients who meet the International Pain Working Group's criteria for central neuropathic pain below the level of the lesion and who have had pain for at least 6 months
- •Patients aged 18-65
- •Pain not attributable to other causes such as rheumatological diseases or diabetes
- •Patients with VAS > 4 despite maximum dose of pharmacological agents (anticonvulsants, antidepressants, narcotics), exercise and physical therapy agents, taking into account renal function tests and other comorbidities
排除标准
- •History of epilepsy
- •Metallic implant in the scalp
- •Cochlear implant
- •Spinal cord stimulator
- •Presence of psychiatric illness
研究组 & 干预措施
active rTMS primer motor cortex
Active Comparator
干预措施: active TMS (Device)
rTMS anterior cingulate gyrus
Experimental
干预措施: active TMS (Device)
sham rTMS primer motor cortex
Sham Comparator
干预措施: sham TMS (Device)
结局指标
主要结局
visual analog scale
时间窗: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment
The assessment of pain using a 10 cm visual analogue scale (VAS), separately for daytime and night-time. The assessment will be conducted on a scale of "0 = no pain" to "10 = the most severe pain imaginable".
次要结局
- neuropathic pain scale(first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment)
- Beck Depression Scale(first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment)
- 5-point Likert scale(first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment)
研究者
Ayse Naz Kalem
PM&R Specialist
Ankara Etlik City Hospital
研究点 (4)
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