Evaluation of the Efficacy and Safety of Mepivacaine on the Neurological Sequelae of Cerebral Infarction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- improvement of clinical scores
研究概览
简要总结
A patient, suffering from cortical blindness after a bi-occipital infarction 1 year earlier, regained near-normal vision in the right visual hemifield a few minutes after subcutaneous administration of mepivacaine. The effect was maintained for several days, and was repeated with each injection of mepivacaine. This clinical improvement is associated with functional changes in the peri-lesional areas on resting-state functional MRI.
The investigator team hypothesizes that in some patients with chronic neurological symptoms of stroke, the investigator team will observe a favorable response to subcutaneous mepivacaine injection.
详细描述
A patient, suffering from cortical blindness after a bi-occipital infarction 1 year earlier, regained near-normal vision in the right visual hemifield a few minutes after subcutaneous administration of mepivacaine. The effect was maintained for several days, and was repeated with each injection of mepivacaine. This clinical improvement is associated with functional changes in the peri-lesional areas on resting-state functional MRI. The investigator team hypothesizes that in some patients with chronic neurological symptoms of stroke, investigator team will observe a favorable response to subcutaneous mepivacaine injection.
The team will include patients with clinically significant sequelae of ischemic stroke, as was the case with the initial patient. In addition,
- The team hypothesizes that the mechanism of action is not specific to the visual cortex, and therefore should not be limited to visual scotomas
- It is also preferable to consider only deficits that can be objectively quantified in a sufficiently reliable way to be able to evaluate the effect of the treatment
The investigator teamwill therefore include patients with sequelae of at least one of the following three types:
- motor deficit: score =< 56 on the Fugl-Meyer scale, minimal deficit allowing to observe an improvement of 4 points
- aphasia: score >= 4 on the Aphasia Rapid Test (ART) , minimal deficit allowing to observe an improvement of 4 points
- visual scotoma: observable on a clinical assessment of the visual field "on confrontation"
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke more than 30 days old
- •Age between 18 and 85 years old
- •At least one deficit among:
- •motor deficit: score < 56 on the Fugl-Meyer scale
- •aphasia: score ≥4 on the Aphasia Rapid Test,
- •presence of a clinically observable visual scotoma
- •Having given their written consent
- •Be affiliated with a social security scheme, Universal Medical Coverage (CMU) or any equivalent scheme
排除标准
- •Hypersensitivity to amide-bonded local anesthetics.
- •Atrioventricular conduction disorders requiring permanent electro-systolic training not yet performed.
- •Epilepsy not controlled by treatment.
- •Porphyritic subjects.
- •Patients with a motor deficit (but no aphasia or scotomas) in whom there is spasticity leading to a major reduction in joint amplitude in passive motion
- •Minor patients, under curatorship or guardianship, under legal protection, deprived of liberty, pregnant or breastfeeding women
- •Pathologies involving the vital prognosis or compromising follow-up during the study period
- •Patient undergoing local amine anesthesia in the 7 days preceding V
- •Patients currently treated with no anti-arrhythmics such as tocainide, aprindine and mexiletine
- •Patients with a contraindication to MRI (ferro-magnetic surgical clips, eye implants, metallic foreign body intraocular or in the nervous system, implants or metallic objects likely to contain the radiofrequency field, cochlear implants, cerebral or cardiac pacemaker , implantable cardiac defibrillators)
- •Patients participating in research involving the therapeutic human person who may modify functional recovery (whether by medication or by medical device) or subject to an exclusion period for another research
研究组 & 干预措施
Mepivacaine arm
mepivacaine injection
干预措施: Carbocaine Injectable Product (Drug)
结局指标
主要结局
improvement of clinical scores
时间窗: 1 Day
The response is defined as an improvement 1h (+/- 30min) after injection, compared to the evaluation before mepivacaine injection, on at least one of the clinical scores specific to the symptoms: * language : decrease of at least 4 points on the ART scale (rated from 0 to 26) , or increase of 20% of the number of images correctly named on a standardized battery (DO80, rated from 0 to 80). The rate of 20% corresponds to an effect considered clinically significant, without any "clinically significant minimal change" published to date. * motor skills : increase of at least 4 points on the Fugl-Meyer scale (rated from 0 to 60) corresponding to the "clinically significant minimal change" in the re-education studies * visual field : 20% reduction of a scotoma evaluated in automated static perimetry of Humphrey by the number of deficit areas compared to the total number of areas evaluated (n=43). The rate of 20% corresponds to an effect considered clinically significant
次要结局
- spontaneous language test(1 Day)
- 10 metres walking test(1Day)
- language-related symptoms(1 Day)
- ART scale(1 Day)
- Fugl-Meyer scale(1Day)
- Timed up and go test(1Day)
- Perimetry of Humphrey(1 Day)
- kinetic perimetry(1 Day)
- static perimetry(1 Day)
- NIHSS score changes(1 Day)
- response delay(1 Day)