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

Key facts

Who runs it
Ecole Polytechnique Fédérale de Lausanne
Where
Switzerland1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
12 people, planned
Started
15 Sept 2026
Expected to end
Sept 2028
Type of study
Interventional
Treatments tested
  • TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES)
Record updated
4 August 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 deep vein thrombosis in lower extremities within the past 6 months
  • Must not have current pressure ulcer of the arms, trunk, pelvic area, or lower extremities
  • 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 experienced lower extremity fractures within the last two years
  • Must not present with a flexion contracture >15° at the hip or knee
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • All participantTreatment being tested

    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.

    Treatment: TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
4 August 2026