NCT02817880已完成不适用
Comparison of the Analgesic Effect Between the Motor Cortex Stimulation (tDCS and rTMS) and the Trans-spinal Stimulation (tsDCS ) in the Algoneurodystrophy of Members. A Randomised Clinical Trial. tDCS : Transcranial Direct-current Stimulation rTMS : Repetitive Transcranial Magnetic Stimulation tsDCS : Transcutaneous Spinal Direct Current Stimulation
University Hospital, Grenoble4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年7月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- The Visual numeric scale of pain between the three groups
研究概览
简要总结
The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.
详细描述
- Entry into the study : After informed consent, patients will be randomised into three groups : tDCS, rTMS, tsDCS. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS).
- Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 month.
- The beginning of the treatment : after the baseline, sessions of neurostimulation will begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months.
- After the end of neurostimulation sessions, patients will be followed for 1month.
Throughout their participation in the study, patients will complete their VNS report book (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after neurostimulation).
Patients will have 5 evaluation examinations:
- The first, one just before the beginning of the neurostimulation,
- The second, 1 month after the beginning of neurostimulation
- The third, 3 months after the beginning of neurostimulation
- And the last one, 1 month after the end of neurostimulation.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's written consent
- •Patient suffering from an algoneurodystrophy for more than a year.
- •Diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy
- •Stable treatment for at least 1 month
- •Patient non-responsive to pharmacological treatments
- •VNS > 3 at the time of screening
排除标准
- •Drug addiction
- •History of epilepsy, head trauma, Psychiatric pathology likely to hamper the progress of the study.
- •Intracranial ferromagnetic material or an implanted stimulator
- •MRI contraindication
- •Algoneurodystrophy due to a nervous lesion
- •Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
结局指标
主要结局
The Visual numeric scale of pain between the three groups
时间窗: Baseline to 1 month
次要结局
- Evolution of the conductance of feet and hands by using Sudoscan(Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180))
- The Clinical Global Impression scale (CGI) between the three groups(Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180))
- The SF12 quality of life questionnaire between the three groups(Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180))
- The Neuropathic Pain Symptom Inventory scale (NPSI) between the three groups(Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180))
- Modifications of the sensori-motor cortical cards by using a MRI(Baseline, and 1 month after the end of the treatment (Day 180))
- The Hospital Anxiety and Depression scale (HAD) between the three groups(Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180))
研究者
研究点 (4)
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