Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System
研究概览
简要总结
The HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.
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
- •18 years of age or older
- •Must provide and sign the Informed Consent prior to any study related procedures
- •Spinal cord injury lesion level between C3 and T6 (inclusive)
- •SCI ≥ 1month
- •Confirmed orthostatic hypotension
- •Stable medical, physical and psychological condition as considered by the investigators
- •Able to understand and interact with the study team in French or English
- •Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
排除标准
- •SCI related to a neurodegenerative disease
- •Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- •The inability to withhold antiplatelet/anticoagulation agents perioperatively
- •History of myocardial infarction or cerebrovascular event within the past 6 months
- •Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
- •Clinically significant mental illness in the judgement of the investigators
- •Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment
- •Presence of significant pressure ulcers
- •Recurrent urinary tract infection refractory to antibiotics
- •Presence of indwelling baclofen or insulin pump
- •Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding,
- •Lack of safe contraception for women of childbearing capacity,
- •Intention to become pregnant during the course of the study,
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Enrolment of the investigator, his/her family members, employees, and other dependent persons.
研究组 & 干预措施
all participants
All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)
干预措施: ARC-IM Investigational System implantation (Device)
结局指标
主要结局
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System
时间窗: Throughout study, an average of 26 months
Evaluate the safety of ARC-IM Therapy at supporting management of hemodynamic instability in participants with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension
次要结局
- Orthostatic head-up tilt test (hemodynamic stability assessment)(Baseline ; at 1 - 6.5 - 13 - 26 months after the implantation)
- Modified Ashworth Scale (MAS) (spasticity assessment)(Baseline ; at 1 - 13 months after the implantation)
- SCIM III (daily life performance assessment)(Baseline ; at 1 - 6.5 - 13 months after the implantation)
研究者
Jocelyne Bloch
Prof.
Centre Hospitalier Universitaire Vaudois