JPRN-jRCTs052190110已完成2 期
Trial of long-term rTMS therapy for intractable neuropathic pain - TMS-P-07
Hosomi Koichi0 个研究点目标入组 30 人开始时间: 2020年2月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
This study was an exploratory, randomized, placebo-controlled trial to evaluate the efficacy and safety of 10-Hz repetitive transcranial magnetic stimulation over the primary motor cortex of hand area in 30 patients with neuropathic pain in the upper extremity. The primary outcome didn't show that the active stimulation group wasn't more effective than the sham. No serious adverse eventswere observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients with neuropathic pain longer than 6 months after onset.
- •2) Baseline VAS of pain intensity: 40 to 95/100 mm
- •3) Patients with currently prescribed medication for NP or a history of being prescribed multiple medications for NP without achieving pain control
- •4) Patients with continuous pain at upper extremity
- •5) Age >= 20 years
- •6) Patients with written consent for participation in this study
- •1) Average of pain diary (NRS) 1 week before intervention: >= 4
- •2) Average of VAS 1 week before intervention: >= 40 mm
排除标准
- •1) Patients with dementia (MMSE =< 23)
- •2) Patients with severe aphasia and cognitive dysfunction
- •Patients with severe mental illness
- •Patients with a history of drug abuse or addiction (including alcoholism) within the last one yea
- •3) Patients with suicidal thoughts
- •4) Patients with a history of seizures
- •5) Patients with cardiac pacemakers or other types of implantable stimulator (except implantable spinal cord stimulator)
- •6) Patients with metal object (excluding Titanium products) embedded in the head
- •7) Patients with implantable pump or implantable ventricular assist devices
- •8) Pregnant patients
- •9) Patients unable to answer the questionnaires
- •10) Patients whose stimulus target upper extremities are in complete paralysis condition
- •11) Patients who received rTMS within the last six months before obtaining consent
- •12) Patients who enrolled in any other clinical trials or clinical studies within the last three months before obtaining consent
- •13) Others not applicable person determined by the investigators
- •1) Patients who are unable to comply combination prohibited or combination restricted therapies during the observation period
- •2) Patients who are able to fill in the evaluation forms for less than five days during the observation period
- •3) Others not applicable person determined by the investigators
研究者
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