VALSE: Integration of Neuromodulation and Exoskeleton Systems for Mobility in Individuals With Chronic Spinal Cord Injury (VALSE)
研究概览
地位
条件
详细说明
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.
As an early feasibility investigation, the study aims to generate preliminary safety and usability data on the combined use of spinal neuromodulation and robotic assistance during mobility tasks. The results will support the development of future neuroprosthetic solutions designed to improve walking ability, independence, and quality of life for people living with SCI.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Henri Lorach, PhD
- 电话号码：+41 77 495 50 48
- 邮箱：henri.lorach@epfl.ch
研究联系人备份
- 姓名：Jocelyne Bloch, Prof.
- 电话号码：+41 79 556 29 51
- 邮箱：jocelyne.bloch@chuv.ch
学习地点
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Canton of Vaud
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Lausanne、Canton of Vaud、瑞士、1005
- Centre Hospitalier Universitaire Vaudois (CHUV)
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接触：
- Jocelyne Bloch
- 电话号码：0795568979
- 邮箱：Jocelyne.bloch@chuv.ch
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：All participant
All participants receive the same intervention. Each participant will complete 3 predefined study periods within 1 year of enrolment. Each study period lasts 3 weeks, and study periods are separated by a minimum interval of 1 month. |
Participants will use the VALSE system, which combines the TWIICE Rise 1.0 robotic exoskeleton with epidural electrical stimulation (EES) delivered through previously implanted neuromodulation systems.
The system is intended to support upright mobility and overground walking in individuals with chronic spinal cord injury (SCI) who are currently enrolled in, or have completed key phases of, neuromodulation clinical trials at CHUV, including Think2Go (NCT06243952), STIMO-BSI (NCT04632290), and BoxSwitch (NCT05942339).
The TWIICE exoskeleton provides robotic gait assistance, while EES facilitates activation of spinal motor circuits below the level of injury.
Exoskeleton movements are initiated and controlled through participant-generated inputs, including finger-click commands and, where applicable, brain-derived control signals from previously implanted brain-spine interface systems.
The VALSE system is used in supervised clinical and controlled real-world.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Preliminary safety
大体时间：From enrollment until the end of study timepoint, up to 1 year after enrollment.
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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)
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From enrollment until the end of study timepoint, up to 1 year after enrollment.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of the experimental session conditions
大体时间：At each in-clinic training session during the three study periods, up to 1 year after enrollment.
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Location and type of ground walked on.
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At each in-clinic training session during the three study periods, up to 1 year after enrollment.
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Number of steps
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Total number of steps recorded by the exoskeleton during each experimental (EX) session.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Step frequency
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Average step frequency (cadence) recorded by the exoskeleton during each experimental (EX) session.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Mid-stride pauses
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Number of mid-stride pauses recorded by the exoskeleton during each experimental (EX) session.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Distance walked
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Total distance walked recorded by the exoskeleton during each experimental (EX) session.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Walking time
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Total walking time recorded by the exoskeleton during each experimental (EX) session.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Standing time
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Total standing time recorded by the exoskeleton during each experimental (EX) session.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Kinematic gait parameters
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Kinematic gait parameters recorded during overground walking and functional locomotor tasks (change of walking speed, stepping over and turn around obstacles, climb stairs, walk with cognitive load (e.g., counting backward by threes)) using the VALSE system.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Electromyographic (EMG) activity
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Muscle activation patterns recorded by surface electromyography during overground walking and functional locomotor tasks while using the VALSE system.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Brain-computer interface (BCI) performance
大体时间：At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Brain-computer interface performance metrics recorded during overground walking and functional locomotor tasks while using the VALSE system.
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At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
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Donning and Doffing Time
大体时间：At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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Assessment of the time it takes to put on and take off the system.
Donning time is recorded from the start of preparation until the participant is fully ready for ambulation.
Doffing time is recorded from the start of removal until the participant is fully disengaged from the system.
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At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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Level of Assistance (LOA)
大体时间：At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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Assessment to evaluates the amount of physical support required by the participant during walking and mobility activities with the device.
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At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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System Usability Scale (SUS)
大体时间：At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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A validated 10-item questionnaire measuring usability across multiple domains.
Scores range from 0-100, with higher values indicating greater usability.
Will be filled in by participants and physiotherapists.
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At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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ASA Task Load Index (NASA-TLX)
大体时间：At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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A 6-dimension tool assessing perceived workload (mental demand, physical demand, temporal demand, performance, effort, frustration).
Will be filled in by participants and physiotherapists.
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At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
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合作者和调查者
调查人员
- 首席研究员：Jocelyne Bloch, Prof.、Centre Hospitalier Universitaire Vaudois (CHUV)
出版物和有用的链接
一般刊物
- Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.
- Gorgey AS, Gill S, Holman ME, Davis JC, Atri R, Bai O, Goetz L, Lester DL, Trainer R, Lavis TD. The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. Ann Clin Transl Neurol. 2020 Feb;7(2):259-265. doi: 10.1002/acn3.50983. Epub 2020 Feb 5.
- Hong E, Gorman PH, Forrest GF, Asselin PK, Knezevic S, Scott W, Wojciehowski SB, Kornfeld S, Spungen AM. Mobility Skills With Exoskeletal-Assisted Walking in Persons With SCI: Results From a Three Center Randomized Clinical Trial. Front Robot AI. 2020 Aug 4;7:93. doi: 10.3389/frobt.2020.00093. eCollection 2020.
- Vouga T, Fasola J, Baud R, Manzoori AR, Pache J, Bouri M. TWIICE One powered exoskeleton: effect of design improvements on usability in daily life as measured by the performance in the CYBATHLON race. J Neuroeng Rehabil. 2022 Jun 27;19(1):63. doi: 10.1186/s12984-022-01028-0.
- Zhang T, Jia Y, Wang N, Chai X, He Q, Cao T, Mu Q, Lan Q, Zhao J, Yang Y. Recent advances in potential mechanisms of epidural spinal cord stimulation for movement disorders. Exp Neurol. 2025 Oct;392:115330. doi: 10.1016/j.expneurol.2025.115330. Epub 2025 Jun 4.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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