Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Ashworth Scale
研究概览
简要总结
The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy
详细描述
PROJECT Lateral Cord Stimulation was thought by the author to be employed in patients with spastic cerebral palsy with the aim to improve tonus, motor function and speech.
Nevertheless, as it has been demonstrated as acting on the basic phenomena related with spasticity, it's to say the propagated spinal responses, its use could be extended to other forms of spastic disease, like spastic limbs post stroke, brain congenital malformations producing spasticity and motor disorders as the main signs, post anoxic encephalopathy, etc.
In this preliminary clinical trial, classed as phase 3, our sample must be very limited to assure stable conditions for statistical significance, hence our group is going to be circumscribed to certain conditions and pathology.
In the future, as long the method could spread its use, the extension on indications in other pathological conditions is advisable thus, its possibilities of marketing could be enlarged with its use in a broader spectrum of spastic patients.
Calculated risks are similar to those related with the ancient surgical technique called "Scoville"technique, currently employed time ago for cervical discectomy (6) Investigational plan The purpose of this clinical trial is to release spasticity and by this means improve the condition of patients with spastic cerebral palsy by extradural lateral cord electrical stimulation, by using currently employed electrodes and neurostimulators Those devices are already FDA approved and currently used for Dorsal Column Stimulation with the objective to treat chronic Pain and spasticity (Spasmodic Torticollis).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged sixteen or older
- •Spastic Cerebral Palsy with stable condition
- •Motor disability unilateral or predominantly unilateral.
- •Troubles of speech clinically evident.
- •Normal or Slightly sub-normal I.Q
- •No psychiatric disorders.
排除标准
- •Severe cardiac or respiratory troubles
- •Fixed abnormal postures (except if previously corrected by orthopedic surgery)
- •Chronic recurrent bronchial or pulmonary infections
- •Chronic recurrent urinary infections
- •Severe osteoporosis on affected limbs
- •Chronic skin ulcerations.
研究组 & 干预措施
Spasticity, Cerebral Palsy
To perform a Lateral spinal cord surgical implant of electrodes for electrical neuromodulation of a cohort of selectyed patients with refractory Spastic Cerebral Palsy To compare spasticity and speech trouble´s evolution on a cohort of treated patients, by evaluating their pre and post operative status into one year follow up.
干预措施: Lateral spinal cord surgical implant of electrodes (Device)
结局指标
主要结局
Ashworth Scale
时间窗: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
The Ashworth scale has 5 points, they are: 1) no increase in muscle tone; 2) slight increase giving a catch when part is moved in flexion or extension; 3) more marked increase in tone but only after part is easily flexed; 4) considerable increase in tone; and 5) passive movement is difficult and affected part is rigid in flexion or extension
次要结局
- Barthel Index(Day 0 baseline evaluation. One post operative evaluation every 30 day during six months)
研究者
Juan Carlos M. Andreani MD
MD
Sociedad Argenttina de Neuromodulación