Observational Study of the Analgesic Effect of Treatment With rTMS in Patients Suffering From Chronic Neuropathic Pain Refractory to Conventional Treatment and Monitored and Evaluated in Consultation Multidisciplinary Chronic Pain in Lower Normandy
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- NPSI (Neuropathic Pain Symptom Inventory)
研究概览
简要总结
For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted through a neurosurgical procedure. This is common practice at the University Hospital of Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in our center only a non-invasive technique for patients challenged with brain surgery, since according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated to the repetition of sessions.
Assessment centers and the treatment of pain allow a multidimensional assessment, bio-psycho-social of patients in order to optimize their management and experience efficiently analgesics first- and second-line.
We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation parameters reproduced according to a literature review, during 3 months after 5 active sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory to treatment of first and second line, followed by multidisciplinary center specializing in chronic pain Lower Normandy. The quality of life will also be assessed by validated scales, and the results will be compared to the literature data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 to 70 years with:
- •Pain lasting for more than six months;
- •Monitoring in CETD in Normandy;
- •Having had a bio-psycho-social assessment and have been the subject of a multidisciplinary discussions recorded in the medical record;
- •Presenting unilateral neuropathic pain, central or peripheral origin:
- •may affect the face,
- •upper limb,
- •or hémicorps but including at least the upper limb;
- •With neuropathic pain screening test positive (≥ DN4 4/10);
- •etiology objectified by further examinations (MRI, scanner, or EMG, PES MEP);
- •Resistant to usual treatments: less than 50% improvement compared to the initial pain (EN or EVA) in patients who received an effective dose for treatment of first and a second intention.
排除标准
- •Contraindications of rTMS:
- •Brain implanted ferromagnetic material,
- •Implanted neurostimulator (cortical and deep brain, spinal cord)
- •Cochlear Implants
- •Active epilepsy (seizures despite existence of a current treatment)
- •Hearing loss or current taking ototoxic drugs (aminoglycosides, cisplatin)
- •Pregnancy, breastfeeding, lack of effective contraception for patients of childbearing age
- •Psychiatric illness decompensated
- •Cancer pain and post-chemotherapy
- •severe cognitive disorders
结局指标
主要结局
NPSI (Neuropathic Pain Symptom Inventory)
时间窗: baseline and after 17 weeks
Analysis of analgesic efficacy: evolution of NPSI (Neuropathic Pain Symptom Inventory), validated scale in monitoring neuropathic pain, and VAS (visual analogue scale), to fill once a week over a period of 17 weeks, from one week before the first session of rTMS until three months after the last rTMS session.
次要结局
未报告次要终点