Not Yet RecruitingNot Applicable

VALSE: Integration of Neuromodulation and Exoskeleton Systems for Mobility in Individuals With Chronic Spinal Cord Injury

Switzerland12 participantsStarted 2026-09-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 h…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Preliminary safety

Timeframe: From enrollment until the end of study timepoint, up to 1 year after enrollment.

Trial details

NCT IDNCT07745686

SponsorEcole Polytechnique Fédérale de Lausanne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Jocelyne Bloch, Prof.

+41 79 556 29 51 jocelyne.bloch@chuv.ch

View on ClinicalTrials.gov More Spinal Cord Injury trials