NCT04936646招募中不适用
Randomized Double-blind Study of RTMS Analgesic Effect in Chronic Neuropathic Pain. Comparison Between Three Groups: Motor Cortex Stimulation by the Classic Coil B65, Deeper Stimulation by the Coil B70 and Placebo Stimulation. Analysis of Long-term RTMS-induced Brain Changes Using FMRI.
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Evolution of Pain.
研究概览
简要总结
The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:
- Classical rTMS stimulation
- Deeper rTMS stimulation
- Sham rTMS stimulation
详细描述
Conduct of study:
- Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient.
- Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.
- Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks.
- After the end of neurostimulation sessions, patients will be followed for 2 weeks.
- Throughout their participation in the study, patients will plot on a diary form their daily VNS.
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
- Triple (Participant, Investigator, 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
- •Affiliated with social security system
- •Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
- •Patient whose analgesic treatment, is stable for at least 1 month.
- •Patient not responding to conventional treatments
- •Prescreening EVN >3
排除标准
- •History of drug addiction, epilepsy, cranial trauma
- •History of psychiatric disorder
- •Patients previously treated with rTMS
- •Patient with intracranial ferromagnetic material or implanted stimulator
- •New treatment for less than one month
- •Pregnant or Breastfeeding woman
- •Patient who does not understand the study protocol
- •Persons who are protected under the act.
结局指标
主要结局
Evolution of Pain.
时间窗: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better).
次要结局
- Improvement of pain triggered by a stimulus (allodynia).(Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.)
- Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS(Day 60 from the beginning of rTMS treatment compared to baseline.)
- Assessment of Overall Patient Improvement.(Day 30 and day 60 from the beginning of rTMS treatment compared to baseline)
- Quality of Life Improvement.(Day 30 and day 60 from the beginning of rTMS treatment compared to baseline)
- Evolution of Anxiety and Depressive Traits.(Day 30 and day 60 from the beginning of rTMS treatment compared to baseline)
- Evolution of the use of analgesic treatments.(From baseline to day 60.)
- Rate of Responding Patients.(week 7 compared with baseline)
- Analgesic Response Analysis(From baseline to day 60.)
- Evolution of Symptomatological Profiles of Neuropathic Pain.(Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.)
- Sympathetic Autonomic System Injury and Small Fiber Neuropathy.(Day 60 from the beginning of rTMS treatment compared to baseline.)
- Autonomous System Assessement.(Day 60 from the beginning of rTMS treatment compared to baseline.)
研究者
研究点 (2)
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