Spinal Cord Injury
Conditions
Keywords
exoskeleton, Spinal cord stimulation, Brain spine interface
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTTWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES)
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.
Sponsors
Ecole Polytechnique Fédérale de Lausanne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
monocentric, single-arm, non-blinded, non-randomized, interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary safety | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the experimental session conditions | At each in-clinic training session during the three study periods, up to 1 year after enrollment. | Location and type of ground walked on. |
| Number of steps | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Total number of steps recorded by the exoskeleton during each experimental (EX) session. |
| Step frequency | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Average step frequency (cadence) recorded by the exoskeleton during each experimental (EX) session. |
| Mid-stride pauses | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Number of mid-stride pauses recorded by the exoskeleton during each experimental (EX) session. |
| Distance walked | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Total distance walked recorded by the exoskeleton during each experimental (EX) session. |
| Walking time | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Total walking time recorded by the exoskeleton during each experimental (EX) session. |
| Standing time | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Total standing time recorded by the exoskeleton during each experimental (EX) session. |
| Kinematic gait parameters | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | 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. |
| Electromyographic (EMG) activity | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Muscle activation patterns recorded by surface electromyography during overground walking and functional locomotor tasks while using the VALSE system. |
| Brain-computer interface (BCI) performance | At each experimental (EX) session during the three study periods, up to 1 year after enrollment. | Brain-computer interface performance metrics recorded during overground walking and functional locomotor tasks while using the VALSE system. |
| Donning and Doffing Time | At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment. | 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. |
| Level of Assistance (LOA) | At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment. | Assessment to evaluates the amount of physical support required by the participant during walking and mobility activities with the device. |
| System Usability Scale (SUS) | At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment. | 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. |
| 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. | A 6-dimension tool assessing perceived workload (mental demand, physical demand, temporal demand, performance, effort, frustration). Will be filled in by participants and physiotherapists. |
Countries
Switzerland
Contacts
CONTACTJocelyne Bloch, Prof.
CONTACTHenri Lorach, PhD
PRINCIPAL_INVESTIGATORJocelyne Bloch, Prof.
Centre Hospitalier Universitaire Vaudois (CHUV)
Outcome results
None listed