VALSE: Integration of Neuromodulation and Exoskeleton Systems for Mobility in Individuals With Chronic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Preliminary safety
研究概览
简要总结
The purpose of this clinical study is to evaluate the preliminary safety and feasibility of using the VALSE system, which combines spinal cord stimulation with the TWIICE robotic exoskeleton, to support motor recovery and reduce reliance on laboratory-based equipment during rehabilitation in participants with traumatic spinal cord injury. The TWIICE exoskeleton is integrated through the NR system, a platform developed by EPFL. The goal is to assess the clinical safety and practical application of this combined neuroprosthetic approach in a small number of participants, in order to guide future refinements of the device and protocol, support the development of scalable interventions integrating spinal stimulation with robotic assistance, and inform strategies for delivering rehabilitation in more accessible, real-world environments.
详细描述
Spinal cord injury (SCI) disrupts communication between the brain and spinal cord below the lesion, often resulting in severe and permanent motor impairments. Despite advances in rehabilitation, recovery of walking remains limited and restoring mobility is consistently identified as a top priority by individuals living with SCI.
Epidural electrical stimulation (EES) of the spinal cord has emerged as a promising approach to restore movement after paralysis. By activating spinal motor circuits below the lesion, EES can enable standing, stepping, and walking in individuals with chronic SCI. ONWARD Medical has developed the ARC-IM spinal stimulation platform, which is currently being evaluated in several clinical studies, including BoxSwitch (NCT05942339), Think2Go (NCT06243952), and STIMO-BSI (NCT04632290).
In the BoxSwitch trial, optimized spatiotemporal EES protocols enabled participants with chronic SCI to perform standing, stepping, and walking movements. Building on these findings, the Think2Go and STIMO-BSI studies integrated the WIMAGINE implantable electrocorticography (ECoG) system developed by Clinatec (CEA, Grenoble, France) with spinal stimulation, creating a brain-spine interface capable of decoding motor intentions and translating them into spinal stimulation. These studies demonstrated that implantable brain-spine interfaces can restore voluntary control of lower-limb movements and support functional walking after severe paralysis.
Although these technologies have shown encouraging results, their use remains largely restricted to specialized rehabilitation settings. In parallel, robotic exoskeletons have been developed to support overground walking in individuals with SCI. The TWIICE exoskeleton is a lightweight and modular system specifically designed for use beyond rehabilitation centers and may complement spinal stimulation by providing functional support during walking.
In this study, the investigators will evaluate the preliminary safety and feasibility of the VALSE system, which combines the ARC-IM spinal cord stimulation platform with the TWIICE robotic exoskeleton in individuals with chronic traumatic SCI. Participants will be recruited from ongoing clinical studies at Lausanne University Hospital (CHUV), including BoxSwitch (NCT05942339), Think2Go (NCT06243952), and STIMO-BSI (NCT04632290), after completion of the relevant study phases.
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
- •Currently enrolled participants who have completed the relevant phase of their parent study at CHUV: BoxSwitch (NCT05942339, after the optimisation phase), Think2Go (NCT06243952, after the rehabilitation phase, or STIMO-BSI (NCT04632290, after the calibration and training phase of the optional extension with system upgrade),
- •Must have a functional neuromodulation system,
- •Must be at least 18 years old,
- •Must be suffering from non-progressive traumatic spinal cord injury, sustained at least 12 months before signing the consent form,
- •Must weigh less than 100 kg,
- •Must have a standing height between 160 and 190 cm,
- •Must be able to grasp and lift bilateral crutches in a seated position,
- •Must have stable medical, physical and psychological condition as considered by the investigator,
- •Must be able to understand and interact with the study team in 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.
排除标准
- •Must not be diagnosed with severe osteoporosis/penia:
- •Dual Energy X-ray Absorptiometry (DEXA) results indicating a t-score below -3.5 at either the femoral neck or the total proximal femur.
- •Dual Energy X-ray Absorptiometry (DEXA) results indicating a bone mineral density (BMD) < 0.60 gm/cm2 at any knee region (distal femur, proximal tibia)
- •Must not have deep vein thrombosis in lower extremities within the past 6 months.
- •Must not have experienced lower extremity fractures within the last two years.
- •Must not have current pressure ulcer of the arms, trunk, pelvic area, or lower extremities
- •Must not present with a flexion contracture >15° at the hip or knee
- •Must not have severe concurrent medical conditions that contraindicate moderate to intense exercise (e.g., uncontrolled hypertension, coronary artery disease, congestive heart failure).
- •Must not have heterotopic ossification that impairs joint mobility
- •Must not be implanted with a life-supporting medical device (devices implanted in the parent study are not considered life-supporting),
- •Must not be pregnant,
- •Must not be the investigator himself, his/her family members, employees, or other dependent persons.
结局指标
主要结局
Preliminary safety
时间窗: From enrollment until the end of study timepoint, up to 1 year after enrollment.
Occurrence of Serious Adverse Events (SAE) and Adverse Events (AE) that are deemed related or possibly related to the procedure or to the TWIICE exoskeleton in combination with the neuromodulation therapies (VALSE system)
次要结局
- Assessment of the experimental session conditions(At each in-clinic training session during the three study periods, up to 1 year after enrollment.)
- Number of steps(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Step frequency(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Mid-stride pauses(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Distance walked(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Walking time(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Standing time(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Kinematic gait parameters(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Electromyographic (EMG) activity(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Brain-computer interface (BCI) performance(At each experimental (EX) session during the three study periods, up to 1 year after enrollment.)
- Donning and Doffing Time(At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.)
- Level of Assistance (LOA)(At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.)
- System Usability Scale (SUS)(At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.)
- ASA Task Load Index (NASA-TLX)(At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.)
研究者
Jocelyne Bloch
Prof.
Centre Hospitalier Universitaire Vaudois