NCT07234903招募中不适用
ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 4
- 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 ARC-IM Therapy, from implantation up to the end of the study.
研究概览
简要总结
The EIGER study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support and promote recovery of ambulatory functions, such as walking, in people with subacute and chronic spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Must be at least 18 years old and no older than 65 years old at the time of enrollment.
- •Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS).
- •Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region extending 6 cm above the tip of the conus remaining anatomically intact as determined by MRI.
- •Must have sustained their injury either less than 6 weeks prior to baseline (Group "Subacute SCI"), or more than 1 year prior to enrollment (Group "Chronic SCI").
- •Must be suffering from a SCI due to trauma.
- •Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists.
- •Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration).
- •Must be able to understand and interact with the study team in German, French or English.
- •Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.
- •Must provide Informed Consent as documented by signature prior to any study-related procedures.
- •Must have an acceptable or highly effective method of contraception for women of childbearing capacity.
排除标准
- •Must not be pregnant nor breastfeeding.
- •Must not have brain damage.
- •Must not have a history of epilepsy
- •Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study.
- •Must not have previously been injected with stem cells in the spinal cord.
- •Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery.
- •Must not require ventilator support.
- •Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.).
- •Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.).
- •Must not have any anatomical limitations in the implantation area as judged by the investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone damage at area of implantation).
- •Must not require the use of an intrathecal baclofen pump.
- •Must not have any active implanted devices.
- •Must not have any other conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
- •Must not be the investigator him/herself, his/her family members, employees or other dependent persons.
研究组 & 干预措施
Subacute SCI
Experimental
Participants having sustained the injury less than 6 weeks prior to baseline (subacute).
Participants will be provided with the ARC-IM Therapy.
干预措施: ARC-IM Therapy (Device)
Chronic SCI
Experimental
Participants having sustained the injury more than 1 year prior to enrollment (chronic).
Participants will be provided with the ARC-IM Therapy.
干预措施: ARC-IM Therapy (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 ARC-IM Therapy, from implantation up to the end of the study.
时间窗: Continuously throughout the study (up to 6 years)
Assess the preliminary safety of ARC-IM Therapy in participants with subacute and chronic SCI.
次要结局
- Goal Attainment Scale (GAS)(At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery)
- 10-Meter Walk Test (10MWT)(At Baseline, and at 6 weeks, 16 weeks, ad 42 weeks post-surgery)
- 6-Minute Walk Test (6MWT)(At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery)
- American Spinal Injury Association (ASIA) International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI)(At Eligibility, and at 6 weeks, 16 weeks, 42 weeks post-surgery)
- Timed Up and Go (TUG)(At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery)
- Walking Index for Spinal Cord Injury version II (WISCI II)(At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery)
- Berg Balance Scale (BBS)(At Baseline, and at 6 weeks, 16 weeks, 42 weeks post-surgery)
- Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)(At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery)
- Gait Analysis(At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery)
研究者
Jocelyne Bloch
Professor
Centre Hospitalier Universitaire Vaudois
研究点 (4)
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