High Frequency rTMS (Repetitive Transcranial Magnetic Stimulation) Effect Applied on Primary Cortical Motor, on Nociceptive Perception Thresholds in Parkinson's Disease Patients: a Physiopathology Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session
研究概览
简要总结
Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain perception was altered in Parkinson's disease patients and could be related to nociceptive cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an electrophysiological tool which can modify cortical excitability. Its efficacy was demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients. Each group will receive a high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of one week.
The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session with an infraliminary intensity on the primary cortical motor, modulating nociceptive cortical areas activity, could modify the nociceptive threshold perception in Parkinson's patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients:
- •Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
- •Parkinson's disease patients with a score≤3 on the Hoehn and Year scale
- •Patients treated with dopaminergic antiparkinsonian drugs (L-DOPA, dopamine agonists,ICOMT...)
- •Patients with or without neuropathic pain induced by Parkinson's disease
- •Patients without personal or familial epilepsy episode history
- •Patients from 50 to 80 years old (male or female)
- •Patients affiliated to a social protection program
- •Patient with an informed consent given
- •For Healthy volunteers
- •Subjects from 50 to 80 years old (male or female)
- •Subjects without any serious evolutionary pathology or any clinical significant treatment
- •Subjects without chronic pain or disease which can induce neuropathic pain
- •Subjects without personal or familial epilepsy episode history
- •Subjects affiliated to a social protection program
- •Subjects with an informed consent given
排除标准
- •For patients:
- •Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies...)
- •Parkinson's disease patients with a score>3 on the Hoehn and Yahr scale
- •Patients with important tremors during a OFF conditions
- •Patients suffering from a cancer
- •Patients with a neuroleptic treatment
- •Patients under tutelage, curatella or law protection
- •Patients included in an other clinical study
- •Patients unable to fulfil scales of the study
- •Patients with personal or familial epilepsy episode history
- •Contraindication of IRM
- •Pregnant women
- •For Healthy volunteers:
- •Subjects with serious evolutionary pathology or any clinical significant treatment
- •Subjects with chronic pain or disease which can induce neuropathic pain
- •Subjects with personal or familial epilepsy episode history
- •Contraindication of IRM
- •Pregnant women
- •Subjects under tutelage, curatella or law protection
- •Subjects included in an other clinical study
研究组 & 干预措施
healthy volunteers
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
painful Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
painless Parkinson's disease patients
All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session
时间窗: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
次要结局
- Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale(D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn)
- - Clinical evaluation of the severity of the motor handicap of patients using Unified's Parkinson's Disease Rating Scale (UPDRSIII)(D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn)
- Mood assessment using Visual Analogue Scale(D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn)