Is Mental Motor Imagery Training Using "GHOST", a Novel BCI-VR Feedback System (Brain Computer Interface and Virtual Reality) Efficient and Safe for Pain Relief in Phantom Limb Pain After Upper Limb Amputation or Brachial Plexus Lesion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Efficacy of BCI intervention on mean daily pain
研究概览
简要总结
Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.
详细描述
Upper limb's phantom pain, due to amputation or to injury of the brachial plexus are possibly due to maladaptive CNS (central nervous system facility) plasticity and thus could be decreased by retraining the sensorimotor cortex using Mental Motor Imaging guided through a novel BCI-RV feedback system : "Ghost". The aim of this study is to evaluate safety and efficacy of this BCI pain treatment developed by our team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Neuropathic pain / Phantom limb pain
- •Mean pain score >3 centimeter
- •Permanent pain
- •If Plexus Brachial injury : > 6 month
- •If Amputation : at least at wrist level
- •Motor and Sensory deficit : complete or incomplete
- •Informed consent
- •Public Health Insurance
排除标准
- •MRI contraindication
- •Subject included in another interventional study
- •Pregnant women
- •Majors under guardianship or curatorship or safeguard of justice
- •History of associated head injury or any other neurological pathology altering the sensorimotor cerebral system or cognitive abilities and higher functions.
- •Presence of other lesions of the peripheral nervous system that may induce associated neuropathic pain.
- •Head trauma associated altering somatosensory system or cognitive abilities and higher functions
结局指标
主要结局
Efficacy of BCI intervention on mean daily pain
时间窗: month 6
Determination by curve fitting technique (regression analysis) of the peak effect and calculation of the rate of improvement: success if\> 30%
次要结局
- Evaluate the effect of the intervention on anxiety and depression(Day 1, 12, 90, 180)
- Evaluate the effect of the intervention on quality of life: SF36(Day 1, 12, 90, 180)
- Evaluate the performance of subjects to control the neurofeedback system(Day 1, 12, 30)
- Evaluate the effectiveness of the BCI intervention on paroxysmal pains(60 days from day -30 to day + 30 , once a week from Month 1 to month 6)
- evaluating cortical plasticity(Day 1, 12, 30)