Spinal Cord InjuryVALSENCT07745686
VALSE: Integration of Neuromodulation and Exoskeleton Systems for Mobility in Individuals With Chronic Spinal Cord Injury
A study testing TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES) in people with Spinal Cord Injury, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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 join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1005
Jocelyne Bloch, 0795568979, Jocelyne.bloch@chuv.ch
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES)
- Keywords
- exoskeleton, Spinal cord stimulation, Brain spine interface
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment until the end of study timepoint, up to 1 year after enrollment.
Secondary outcomes (14)
Assessment of the experimental session conditions
Location and type of ground walked on.
Measured: At each in-clinic training session during the three study periods, up to 1 year after enrollment.
Number of steps
Total number of steps recorded by the exoskeleton during each experimental (EX) session.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Step frequency
Average step frequency (cadence) recorded by the exoskeleton during each experimental (EX) session.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Mid-stride pauses
Number of mid-stride pauses recorded by the exoskeleton during each experimental (EX) session.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Distance walked
Total distance walked recorded by the exoskeleton during each experimental (EX) session.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Walking time
Total walking time recorded by the exoskeleton during each experimental (EX) session.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Standing time
Total standing time recorded by the exoskeleton during each experimental (EX) session.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Kinematic gait parameters
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.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Electromyographic (EMG) activity
Muscle activation patterns recorded by surface electromyography during overground walking and functional locomotor tasks while using the VALSE system.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Brain-computer interface (BCI) performance
Brain-computer interface performance metrics recorded during overground walking and functional locomotor tasks while using the VALSE system.
Measured: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Donning and Doffing Time
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.
Measured: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
Level of Assistance (LOA)
Assessment to evaluates the amount of physical support required by the participant during walking and mobility activities with the device.
Measured: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
System Usability Scale (SUS)
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.
Measured: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
ASA Task Load Index (NASA-TLX)
A 6-dimension tool assessing perceived workload (mental demand, physical demand, temporal demand, performance, effort, frustration). Will be filled in by participants and physiotherapists.
Measured: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- monocentric, single-arm, non-blinded, non-randomized, interventional
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Jocelyne Bloch, Prof., Principal investigator, Centre hospitalier universitaire vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745686
- Sponsor's protocol ID
- VALSE
- Acronym
- VALSE
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32023011Hong 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.
PubMed 33501260Vouga 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.
PubMed 35761399Zhang 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.
PubMed 40480308Rowald 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.
PubMed 35132264
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALSE: Integration of Neuromodulation and Exoskeleton Systems for Mobility in Individuals With Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07745686
- Acronym / sponsor ID
- VALSE / VALSE
- Conditions
- Spinal Cord Injury
- Keywords
- exoskeleton, Spinal cord stimulation, Brain spine interface
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- monocentric, single-arm, non-blinded, non-randomized, interventional
| Arm | Type | Receives |
|---|---|---|
| All participant | Experimental | Combination Product: TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TWIICE 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. | Combination product | All participant |
Primary outcome
Preliminary safety
Time frame: 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)
14 secondary outcomes
Assessment of the experimental session conditions
Time frame: At each in-clinic training session during the three study periods, up to 1 year after enrollment.
Number of steps
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Step frequency
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Mid-stride pauses
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Distance walked
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Walking time
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Standing time
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Kinematic gait parameters
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Electromyographic (EMG) activity
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Brain-computer interface (BCI) performance
Time frame: At each experimental (EX) session during the three study periods, up to 1 year after enrollment.
Donning and Doffing Time
Time frame: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
Level of Assistance (LOA)
Time frame: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
System Usability Scale (SUS)
Time frame: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
ASA Task Load Index (NASA-TLX)
Time frame: At the last experimental (EX) session of each of the three study periods, up to 1 year after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 32023011Gorgey 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.
- Background: PubMed 33501260Hong 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.
- Background: PubMed 35761399Vouga 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.
- Background: PubMed 40480308Zhang 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.
- Background: PubMed 35132264Rowald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jocelyne Bloch, Prof. principal investigator
Centre hospitalier universitaire vaudois (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES) in people with Spinal Cord Injury, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne Bloch, Prof. (+41 79 556 29 51, jocelyne.bloch@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary safety (time frame: From enrollment until the end of study timepoint, up to 1 year after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07745686, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.