Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety and Preliminary efficacy: 10-Meter Walk Test (10MWT)
研究概览
简要总结
STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).
Patients will participate during 8-12 months, during which there will be:
- Pre-implant evaluations (6-8 weeks)
- Device implantation and stimulation optimization (6-8 weeks)
- Overground rehabilitation training with EES (5-6 months). In the period after implantation, participants need to be present for testing and training, 4 days per week at the CHUV University Hospital in Lausanne (lodging can be provided). It is possible to complement the neuro-rehabilitative training at CHUV with training outside the rehabilitation room by making use of the Home-use system.
At the end of the protocol, the study aims to make the patients walk better and faster. As this is the first study of its kind, success is not guaranteed. However, the potential benefits outweigh the potential risks.
An optional extension of the study up to 3 years is offered. During this period, the patient can continue the training with the Home-use system.
详细描述
STIMO is a First-in-Man (FIM) study with the objective to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI), as it was previously successfully demonstrated in animals.
The study consists of two phases:
A. Main study
The main study lasts about 8-12 months for each individual participant, from signing informed consent to the final test in the study This period can be divided into 3 distinct phases:
- Pre-implant : about 6-8 weeks from informed consent to implant. During this phase, patient will participate during a total of 6 distinct days of evaluations, of which 5 days in Lausanne and 1 day at the assessment center in Zurich. The patient will also participate to 3 weeks of pre-implantation training in a Body Weight Support (BWS) system.
- Implant and stimulation optimization: about 6-8 weeks, including the implantation of the epidural lead and the neurostimulator. In this phase, the optimal stimulation parameters will be determined for the flexing and stretching of both legs. During this period, participants need to be present at the CHUV University Hospital in Lausanne 4-5 days per week (lodging can be provided).
- Rehabilitation training and final evaluation: 4 days per week of rehabilitation training during a period of 5 months, followed by a final evaluation lasting 4 days in Lausanne and 1 day in Zurich. In this phase, the patients receive intensive overground rehabilitation training using a body weight support device in combination with EES, with the aim of significantly improving their walking capabilities. During this period, participants need to be present at the CHUV University Hospital in Lausanne (lodging can be provided) 4 days per week.
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
- •Age 18-65 (women or men)
- •Incomplete SCI graded as AIS A,B,C & D
- •Level of lesion: T10 and above, based on AIS level determination by the PI, with preservation of conus function
- •The intact distance between the cone and the lesion must be at least 60mm
- •Focal spinal cord disorder caused by either trauma or epidural, subdural or intramedullary bleeding
- •Minimum 12 months post-injury
- •Completed in-patient rehabilitation program
- •Able to stand with walker or 2 crutches
- •Stable medical and physical condition as considered by Investigators
- •Adequate care-giver support and access to appropriate medical care in patient's home community
- •Agree to comply in good faith with all conditions of the study and to attend all required study training and visits
- •Must participate in two training sessions before enrolment
- •Must provide and sign Informed Consent prior to any study related procedures
排除标准
- •Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
- •History of significant autonomic dysreflexia
- •Cognitive/brain damage
- •Patient who has spinal canal stenosis
- •Patient who uses an intrathecal Baclofen pump.
- •Patient who has any active implanted cardiac device such as pacemaker or defibrillator.
- •Patient who has any indication that would require diathermy.
- •Patient who has any indication that would require MRI.
- •Patient that have an increased risk for defibrillation
- •Severe joint contractures disabling or restricting lower limb movements.
- •Haematological disorders with increased risk for surgical interventions (increased risk of haemorrhagic events).
- •Participation in another locomotor training study.
- •Congenital or acquired lower limb abnormalities (affection of joints and bone).
- •Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding or not willing to take contraception.
- •Known or suspected non-compliance, drug or alcohol abuse.
- •Spinal cord lesion due to either a neurodegenerative disease or a tumour.
- •Patient has other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
- •Patient is unlikely to survive the protocol follow-up period of 12 months.
研究组 & 干预措施
All patients
Patients will participate during 8-12 months, during which there will be :
- Pre-implant evaluations (6-8 weeks)
- Device implantation and stimulation optimization (6-8 weeks)
- Overground rehabilitation training with EES (5-6 months) In the period after implantation participants need to be present at the CHUV University Hospital in Lausanne 4 days per week for testing and training (lodging can be provided). It is possible to complement the neuro-rehabilitative training at CHUV with a training outside the rehabilitation room by making use of the Home-use system.
An optional extension of the study up to 3 years is offered. During this period, the patient can continue the training with the Home-use system.
干预措施: Device implantation (Procedure)
结局指标
主要结局
Safety and Preliminary efficacy: 10-Meter Walk Test (10MWT)
时间窗: 7 months after implant
10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: comfortable and fast. It yields scores that are valid and reliable for SCI individuals.
Safety and Preliminary efficacy: Weight Bearing Capacity (WBC).
时间窗: 7 months after implant
Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently.
Safety and Preliminary efficacy: Walking Index for Spinal Cord Injury (WISCI II)
时间窗: 7 months after implant
The Walking Index for Spinal Cord Injury is an ordinal scale that has been frequently used in clinical trials as a tool to assess walking function.
次要结局
- Improvement of walking capability: Spinal Cord Independence Measure (SCIM III).(7 months after implant)
- Improvement of walking capability: 6-Min Walk Test (6MWT).(7 months after implant)
研究者
Jocelyne Bloch
Doctor
Centre Hospitalier Universitaire Vaudois