Study of Sensory-motor Cortex Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- cortical plasticity induced by rTMS - - Somatosensory evoked potentials
研究概览
简要总结
The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary goal, the project will analyse possible correlations between the magnitude of cortical plasticity and that of the pain-relieving effect.
In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a cross-over randomized study.
Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4 weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI (motor activation) performed before the first rTMS session and the last day of each session of rTMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •healthy subjects aged from 18 to 70 years, male or female, with social protection, fully informed and having given their written consent.
- •patients :
- •aged from 18 to 80 years, male or female, with social protection , fully informed and having given their written consent.
- •unilateral pharmacoresistant neuropathic pain during at least one year,
- •without any change of the pharmacological treatment since at least one month
排除标准
- •for healthy subjects only:
- •history of chronic pain
- •analgesic medication within 24h before stimulation
- •For patients only: new analgesic treatment within 1 month before consent
- •drug addiction, headache, epilepsy history
- •ferromagnetic intracranial device
- •implanted stimulator
- •absence of contraceptive method for women of childbearing age
研究组 & 干预措施
healthy volunteers
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Patients with resistant pain
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
cortical plasticity induced by rTMS - - Somatosensory evoked potentials
时间窗: just after the isolated 20 Hz or theta-burst stimulation for healthy subjects
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients. * In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session * In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
cortical plasticity induced by rTMS -- fMRI
时间窗: after the 5th day of stimulation (20 Hz or theta-burst) for the patients
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients. * In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session * In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
cortical plasticity induced by rTMS - - Somatosensory evoked potentials
时间窗: just before the isolated 20 Hz or theta-burst stimulation for healthy subjects
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients. * In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session * In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
cortical plasticity induced by rTMS -- fMRI
时间窗: within 1 week before the first day of stimulation (20 Hz or theta-burst) for the patients
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients. * In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session * In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
次要结局
- Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*,(after the 5th day of stimulation. Stats after 40 patients studied.)
- Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*(after the 5th day of stimulation. Stats after 40 patients studied.)
- Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*(within 1 week before the first day of stimulation Stats after 40 patients studied.)
- Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*,(within 1 week before the first day of stimulation Stats after 40 patients studied.)