NCT05111093招募中不适用
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 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.
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
研究点 (2)
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