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

NCT07745686 | Not Yet Recruiting DMC

• 1 other identifier: VALSE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

exoskeleton; Spinal cord stimulation; Brain spine interface

Outcome Measures

Primary Outcomes (1)

• Preliminary safety

  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)

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

Secondary Outcomes (14)

• 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.

Study Arms (1)

All participant

EXPERIMENTAL

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.

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

Interventions

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

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.

All participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 32023011 BACKGROUND

• 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.

  PMID: 33501260 BACKGROUND

• 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.

  PMID: 35761399 BACKGROUND

• 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.

  PMID: 40480308 BACKGROUND

• 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.

  PMID: 35132264 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jocelyne Bloch, Prof.

  Centre Hospitalier Universitaire Vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyne Bloch, Prof.

CONTACT

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

Henri Lorach, PhD

CONTACT

+41 77 495 50 48; henri.lorach@epfl.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: monocentric, single-arm, non-blinded, non-randomized, interventional

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)