Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- composite outcomes : latencies and amplitudes of pneumatic evoked potential
研究概览
简要总结
The stimuli used in the evoked potentials are electrical or laser. They are started and synchronized with the collection of the EEG by signals TTL (transistor-transistor logic). Investigators propose to validate a pneumatic stimulator delivering the compressed air sync with the EEG. It has two advantages over existing stimuli: Is capable of inducing in patients an allodynic response, excessive, painful, in response to a stimulation painless rarely obtained with laser or electrical stimuli. Therefore, the pneumatic stimulation is a means to study allodynic evoked potentials unknown to date.
It must be possible with a single stimulator to explore non-painful sensations and allodynic sensation , compare them with one device. The differences are the abnormal responses. This validation assumes evoked potential recording 1. somatosensory (low stimulation) then 2. allodynic (only in patients). The study therefore provides for the registration 100 potential for each of these two modalities in patients and only for the painless pneumatic modality in volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •of patients :
- •Major Patient
- •Patient affiliated or entitled to a social security scheme
- •Patient with neuropathic pain authenticated by the neurologist, with the presence of allodynia.
- •Patient has given its written consent to participate in the study
排除标准
- •of patients :
- •Diseases affecting the nervous system,
- •Diabetes,
- •Patients who received chemotherapy
- •Pregnant woman
- •Nobody in emergencies
- •A person unable to give consent
- •Inclusion Criteria of healthy volunteers :
- •Major subject
- •Subject affiliated or entitled to a social security scheme
- •Subject has given its consent to participate in the study
- •Exclusion Criteria of healthy volunteers :
- •Diseases affecting the nervous system,
- •Diabetes,
- •Patients who received chemotherapy
- •Pregnant woman
- •Nobody in emergencies
- •A person unable to give consent
研究组 & 干预措施
patient with neuropathic pain with allodynia
干预措施: pneumatic stimulations(allodynic area) (Other)
patient with neuropathic pain with allodynia
干预措施: pneumatic stimulations (healthy area) (Other)
patient with neuropathic pain with allodynia
干预措施: no stimulation (control) (Other)
healthy volunteers
干预措施: pneumatic stimulations no auditory masking (Other)
healthy volunteers
干预措施: no stimulation (control) (Other)
healthy volunteers
干预措施: pneumatic stimulations with audidory masking (Other)
结局指标
主要结局
composite outcomes : latencies and amplitudes of pneumatic evoked potential
时间窗: Day 1
latencies (in ms) and peak-to-peak amplitudes (in μV) were measured on the electrode providing the response with the highest amplitude.
次要结局
- latencies evoked potentials allodynic tires(Day 1)