Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety Measure: occurence of Serious Adverse Event
研究概览
简要总结
The STIMO-2 study aims to investigate TESS-supported rehabilitation training in sub-acute spinal cord injury (< 6 months post-injury). The primary endpoint of this study is to assess the safety and feasibility of TESS. The preliminary effectiveness of the therapy is the secondary study endpoint. The mobility recovery status of patients, who undergo TESS-supported rehabilitation, will be assessed at 12 months post SCI, compared to their predicted recovery expectations based on standard rehabilitation program
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(non-exhaustive list)
- •Patient enrolled in the EMSCI study
- •Age 18 to 70 years old included
- •Focal spinal cord injury due to trauma
- •Patient with history of SCI within the past 6 months (sub-acute SCI)
- •Vertebral lesion T11 or above
- •Psychological condition compatible with study participation
- •Able and willing to fulfil all study procedures
排除标准
- •(non-exhaustive list)
- •Severe or chronic medical disorder pre-existing SCI affecting rehabilitation
- •Active implanted device such as a pacemaker, implantable cardiac defibrillator
- •Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia
- •Pregnant or breast feeding
- •Participation in other interventional study
研究组 & 干预措施
All patients
All patients implanted.
干预措施: STIMO-2 device implantation (Device)
结局指标
主要结局
Safety Measure: occurence of Serious Adverse Event
时间窗: Through study completion, until 12 months after injury
Occurrence of Serious Adverse Event that are deemed related or possibly related to study procedure or to study investigational system
Feasibility Measure: use of TESS stimulation (in minutes) for improved mobility
时间窗: Through study completion, until 12 months after injury
Measure of the absolute and relative usage of TESS (in minutes) during mobility rehabilitation sessions.
次要结局
- Preliminary effectiveness: mobility assessment using SCIM-III mobility score(Through study completion, until 12 months after injury)
- Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance(Through study completion, until 12 months after injury)
研究者
Jocelyne Bloch
Coordinating investigator
Ecole Polytechnique Fédérale de Lausanne