Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Preliminary safety of the ARC Therapy
研究概览
简要总结
The purpose of this pre-market clinical study is to assess the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System at supporting mobility in participants who have previously received a spinal array and an implantable pulse generator (IPG) either through the STIMO protocol (NCT02936453) or similar studies conducted abroad. They will be proposed to exchange their currently implanted system with components of the newly developed ARC-IM Lumbar system. The goal is to improve more effective lower-limb motor activities, while also simplifying the personal at-home use of the system. In addition, this study aims to evaluate the potential effect of ARC Therapy on muscle tone, bladder, bowel and sexual functions, and quality of life of the participants.
Preliminary safety and efficacy will be assessed in both the short term and throughout the duration of the study (from the surgery to 36 months after the implantation of the ARC-IM Lumbar system).
详细描述
Studies have shown that using Electrical Epidural Stimulation (EES) could improve considerably the functional movements after paralyzing SCI. In the STIMO study (NCT02936453), the investigational system was mainly composed of medical devices developed for other indications and used off-label, allowing only a limited tuning of EES protocols. To overcome this limitation, we propose to conduct a study in which a new platform will be investigated. This new therapy, named ARC Therapy, features the ARC-IM implantable pulse generator with an optimized communication system and the ARC-IM implantable leads supporting stimulation protocols specifically developed for effective activation of motor neurons.
The study will take place at the CHUV (Lausanne, Switzerland). A maximum of 8 participants will be enrolled in the study and implanted with an ARC-IM IPG. Patients who previously received an implantation in international studies for continuous electrical stimulation can enroll in the current BoxSwitch study. Replacement of their currently implanted IPG and lead will be assessed on a case-by-case manner considering current status of their implanted devices, technical and surgical compatibility with the newly proposed ARC-IM Lumbar system components.
The study intervention consists of several phases preceded by pre-screening:
Screening and enrollment, baseline and pre-implantation assessments, surgery, optimization phase, short-term assessments, independent use phase and follow-up assessments at months 12, 24 and 36. Measures will be performed before surgical intervention and at regular intervals during the study.
The total duration of the study will be approximately 48 months (up to 36 months/participant).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings.
- •SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C & D
- •SCI ≥ 12months
- •SCI lesion level T10 and above with preservation of conus function
- •SCI due to trauma
- •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
- •Must provide and sign the Informed Consent prior to any study-related procedures
排除标准
- •Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- •History of myocardial infarction or cerebrovascular event within the past 6 months
- •Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
- •Any active implanted cardiac device such as pacemaker or defibrillator
- •Any indication that would require diathermy
- •Any indication that would require MRI
- •Any anatomical limitations in the implantation area as judged by the investigators
- •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
- •Presence of indwelling baclofen or insulin pump
- •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
- •Enrolment of the investigator, his/her family members, employees, and other dependent persons
- •Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding
结局指标
主要结局
Preliminary safety of the ARC Therapy
时间窗: Through study completion (expected 3 years)
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM system.
次要结局
- 6 Minutes Walk test (meters)(Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months)
- International Standards For Neurological Classification of Spinal Injury (ISNCSCI)(Baseline, 12 months, 24 months and 36 months)
- Walking Index for Spinal Cord Injury (WISCI II)(Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months)
- Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)(Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months)
- Neuromuscular Recovery Scale (NRS)(Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months)
- Modified Ashworth Scale (MAS)(Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months)
- Spinal Cord Independence Measure (SCIM III)(Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months)
- 10 Meters Walk test (m/s)(Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months)
- Quality of Life questionnaires(Monthly during the first year)
研究者
Jocelyne Bloch
Professor, Neurosurgeon
Centre Hospitalier Universitaire Vaudois