Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus.
研究概览
简要总结
In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This purpose of this study is to realise a precise mapping of the primary motor cortex post brachial plexus avulsion.
The principal endpoints is to identify and test the reliability of a muscular marker for which the cortical representation is localized immediately next to the superior member area. Several muscles of cephalic, cervical and chest area will be investigate.
The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional MRI.
Concerning mTMS, several methods will be tested: best position on the scalp, realisation of outputs maps with extreme points average method, with mass center method.
Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand, blow up and down abdomen, eyes winking.
Statistical tests will confirm the best muscle candidate and will permit to evaluate the reliability of the method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all groups: informed consent, social insurance
- •For group 1 "painful BPA": consulting to the Nantes'UH for pain of BPA, EVA≥4, neurological deficiency partial or total
- •For group 2 "painless BPA": EVA<4, neurological deficiency partial or total, matching with group 1 on the neurological deficiency
- •For group 3 "Healthy": matching with group 1 on age ±10 years
排除标准
- •No informed consent
- •Medical history of epilepsy
- •Pregnant women
- •Contra-indication to MRI
结局指标
主要结局
Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus.
Spatial coordinates (xyz): calculation of the center of gravity of cortical surface suggestive of a specific muscle, using data acquired during each session.
次要结局
- Evaluation of primary outcome depending on cortical center
- Evaluation of primary outcome depending on the center of cortical area
- Evaluation of primary outcome depending on cortical surface
- Pain intensity
- Ghost sensations intensity
- Amplitude of PEM