Spinal Cord InjuriesThink2GoNCT06243952

Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation

A study testing ARC-BSI Lumbar system in people with Spinal Cord Injuries and Paraplegia, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of lower limbs in participants with chronic spinal cord… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Spinal Cord Injuries, Paraplegia
What is being tested?: ARC-BSI Lumbar system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteSwitzerland
Study dates: 3 May 2024to Jul 2030
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Must provide Informed Consent as documented by signature (Appendix Informed Consent Form) prior to any study-related procedures,
Must be at least 18 years old and no older than 60 years old at the time of enrolment,
Must be suffering from non-progressive traumatic spinal cord injury,
Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification,
Must have completed primary standard of care rehabilitation,
Must have stable medical, physical and psychological condition as considered by the investigator,

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Must be lesioned at T10 or above, based on AIS level determination by the investigator, with preservation of conus function,
Must have sustained the injury at least 12 months before signing the consent form,
Must have residual upper limb function (capable of using a manual wheelchair),
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 use safe contraception for women of childbearing capacity.

Who cannot join

Must not be pregnant nor breast feeding,
Must not have the intention to become pregnant during the course of the study,
Must not have brain damage,
Must not have history of epilepsy,
Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study, except for VALSE study conducted at CHUV,
Must not have previously been injected with stem cells in the spinal cord,

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Must not have any hematological disorders with increased risk for surgical intervention,
Must not require ventilator support,
Must not have limitation of walking function based on accompanying (Central Nervous System (CNS)) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders),
Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc.),
Must not display spinal stenosis or post traumatic damage at location of implantation,
Must not require the use of an intrathecal baclofen pump,
Must not be implanted with a device such as pacemakers or defibrillators,
Must not have any indication that would require Magnetic Resonance Imaging (MRI),
Must not suffer from congenital nor acquired lower limb abnormalities (affection of joints or bones).
Must not be the investigator himself, his/her family members, employees or other dependent persons.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

CHUV
Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

The goal is to establish a direct bridge between the motor intention of the participant and the the spinal cord below the lesion, which should not only improve or restore voluntary control of legs movement and support immediate locomotion, but also promote neurological recovery when combined with neurorehabilitation.

Read the detailed description

In a current first-in-human clinical trial, called STIMO (ClinicalTrials.gov, NCT02936453), Electrical Epidural Stimulation (EES) of the spinal cord is applied to enable individuals with chronic severe spinal cord injury (SCI) to complete intensive locomotor neurorehabilitation training. In this clinical feasibility study, EES immediately enhances walking function and, with repeated use as part of the EES-assisted neurorehabilitation program, improves leg motor control and neurological recovery in severe SCI participants to a certain extent. Linking brain activity to spinal stimulation, as shown in preclinical and clinical studies, enhances usability of EES and neurological recovery.

Clinatec (CEA, Grenoble, France) has developed an implantable electrocorticogram (ECoG) recording device with a 64-channel epidural electrode array called WIMAGINE capable of recording electrical signals from the motor cortex for an extended period and with a high signal to noise ratio. This ECoG-based system allowed tetraplegic patients to control an exoskeleton (Clinicaltrials.gov, NCT 02550522) with up to 8 degrees of freedom for the upper limb control. This device has been implanted in 5 chronic participants so far; one of them has been using this system both at the hospital and at home for more than 3 years.

The ECoG WIMAGINE technology has been combined with EES in the current first-in-human clinical trial STIMO-BSI (Brain Spine Interface) (Clinicaltrials.gov, NTC04632290): with the WIMAGINE technology, cortical motor intentions for leg movements are recorded, and real-time decoding translates brain signals into EES commands. This digital bridge empowered a chronic SCI participant, who has been part of the STIMO clinical trial, to regain leg motor control by volitional fine-tuned EES amplitudes enabling standing, walking and adapting to diverse terrains, demonstrating the efficacy of the BSI. Moreover, BSI-assisted neurorehabilitation mediated neurological improvements after three years of stable performance of the patient, that persisted even when the BSI was switched off.

In this study, the investigators will assess the preliminary safety and effectiveness of ECoG-controlled EES in individuals with chronic SCI who have not previously participated in STIMO clinical trial, to establish a direct bridge between the motor intention and the spinal cord below the lesion. This could improve or restore voluntary control of legs movement as well as promote neurological recovery when combined with neurorehabilitation. The WIMAGINE ECoG system will be coupled with the ARC-IM purpose-built spinal cord stimulation technology in the ARC-BSI Lumbar system. An equivalent technology (ARC-BSI Cervical system) is currently used in the ongoing UP2 clinical study (Clinicaltrials.gov, NCT05665998) for upper limb rehabilitation in patients with cervical spinal cord injury.

Conditions: Spinal Cord Injuries, Paraplegia
Being tested: ARC-BSI Lumbar system
Keywords: Spinal cord stimulation, Brain computer interface, Brain spine interface
Medical subject headings: Spinal Cord Injuries, Paraplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARC-BSI Lumbar systemDevice
Implantation of a 64 channel - ECoG array over the sensory motor cortex of the lower limbs, combined with an implantation of 16 channel spinal cord stimulation system over the lumbar region. The decoded motor intentions are driving the implanted spinal cord stimulation system. Brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements.

Study groups in NCT06243952
Study group	Role	What they receive
All participants	Experimental	All participants receive the same intervention. Receives: Device: ARC-BSI Lumbar system

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 ARC-BSI Lumbar System.
Measured: Through study completion (implantation up to end of study - average of 1 year)

Secondary outcomes (13)

10 Meters Walk Test (10MWT)
Clinical measure to assess walking speed (in m/s) over 10 meters.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
6 Minutes Walk Test (6MWT)
Submaximal test to assess endurance during 6 minutes of walking.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Timed Up and Go (TUG)
Timed test of functional mobility (stand-up, walk, turn around, sit-down)
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Walking Index for Spinal Cord Injury (WISCI II)
Clinical tool to capture the extent and nature of assistance a person with SCI requires to walk, on an ordinal scale of 20 levels, from the most severe impairment (level 0) to the least severe impairment (level 20).
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Berg Balance Scale (BBS)
Test to measure static balance and fall risk among adults by assessing the performance at functional tasks with a 14-item scale. From 0 to 56, higher scores mean a better outcome.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Neuromuscular Recovery Scale (NRS)
Clinical assessment tool that quantifies recovery from spinal cord injury by measuring functionally relevant motor tasks without compensation strategies. The trunk and lower extremities recovery will be assessed on 10 items.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)
Observational gait assessment that includes 3 key domains of walking function, where 0 is the minimum and worst outcome: gait parameters (maximum score of 20 points), assistive devices (each limb scored individually - maximum score of 14 points), temporal distance (maximum score of 5 points).
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
EMG-based Gait Analysis
Evaluation of locomotion parameters during different walking tasks (walking on a treadmill, walking over ground, "parcours" with obstacles and different surfaces), assessing biomechanics of movement through the acquisition of electromyographic data (electrical activity, in millivolts, associated to muscular fibers contraction) with placement of wearable sensors on the legs muscles.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Kinematics-based Gait Analysis
Evaluation of locomotion parameters during different walking tasks (walking on a treadmill, walking over ground, "parcours" with obstacles and different surfaces), assessing biomechanics of movement through the acquisition of kinematic data (displacement in the 3 directions of space, in millimeters) with placement of wearable markers on the legs joints.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Presence of visible movements during single joints movements attempts, measured in angular displacement of the joint (degrees, °)
Assessment of the presence of visible movements for right and left hip (flexion), ankle (dorsiflexion) and knee (extension).
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Spasticity assessment (Modified Ashworth Scale - MAS)
Resistance of a muscle to a passive range of motion about a single joint (6-points nominal scale).
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
ASIA impairment scale - International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Somato-Sensory Evoked Potential (SSEP)
Electrophysiological measure that evaluates the transmission of electrical pulses resulting from electrical stimulation of the dorsal roots of the spinal cord through the ARC-IM stimulation lead, by recording the cortical response with the WIMAGINE implant.
Measured: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 2024Jul 2030

First posted6 Feb 2024
Study start3 May 2024
Primary completionJul 2030 (estimated)
Study completionJul 2030 (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 InjuriesStudies 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: 3 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06243952
Sponsor's protocol ID: Think2Go
Acronym: Think2Go
Status last verified: Oct 2025
First submitted: 11 Dec 2023
Last updated: 28 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
PubMed 30382197
Bonizzato M, Pidpruzhnykova G, DiGiovanna J, Shkorbatova P, Pavlova N, Micera S, Courtine G. Brain-controlled modulation of spinal circuits improves recovery from spinal cord injury. Nat Commun. 2018 Aug 1;9(1):3015. doi: 10.1038/s41467-018-05282-6.
PubMed 30068906
Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013.
PubMed 24305828
Lorach H, Galvez A, Spagnolo V, Martel F, Karakas S, Intering N, Vat M, Faivre O, Harte C, Komi S, Ravier J, Collin T, Coquoz L, Sakr I, Baaklini E, Hernandez-Charpak SD, Dumont G, Buschman R, Buse N, Denison T, van Nes I, Asboth L, Watrin A, Struber L, Sauter-Starace F, Langar L, Auboiroux V, Carda S, Chabardes S, Aksenova T, Demesmaeker R, Charvet G, Bloch J, Courtine G. Walking naturally after spinal cord injury using a brain-spine interface. Nature. 2023 Jun;618(7963):126-133. doi: 10.1038/s41586-023-06094-5. Epub 2023 May 24.
PubMed 37225984
Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Moriniere B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.
PubMed 31587955

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation
ClinicalTrials.gov ID: NCT06243952
Acronym / sponsor ID: Think2Go / Think2Go
Conditions: Spinal Cord Injuries, Paraplegia
Keywords: Spinal cord stimulation, Brain computer interface, Brain spine interface
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 3 participants (estimated)
Lead sponsor: Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
Study start: 3 May 2024 (actual)
Primary completion: Jul 2030 (estimated)
Study completion: Jul 2030 (estimated)
First posted: 6 Feb 2024 (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.

Detailed description

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 participants	Experimental	Device: ARC-BSI Lumbar systemAll participants receive the same intervention.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Must provide Informed Consent as documented by signature (Appendix Informed Consent Form) prior to any study-related procedures,
Must be at least 18 years old and no older than 60 years old at the time of enrolment,
Must be suffering from non-progressive traumatic spinal cord injury,
Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification,
Must have completed primary standard of care rehabilitation,

Key exclusion criteria (16 listed)

Must not be pregnant nor breast feeding,
Must not have the intention to become pregnant during the course of the study,
Must not have brain damage,
Must not have history of epilepsy,
Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study, except for VALSE study conducted at CHUV,

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
ARC-BSI Lumbar systemImplantation of a 64 channel - ECoG array over the sensory motor cortex of the lower limbs, combined with an implantation of 16 channel spinal cord stimulation system over the lumbar region. The decoded motor intentions are driving the implanted spinal cord stimulation system. Brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements.	Device	All participants

Primary outcome

Preliminary safety
Time frame: Through study completion (implantation up to end of study - average of 1 year)
Occurrence of Serious Adverse Events (SAE) and Adverse Events (AE) that are deemed related or possibly related to the procedure or to the ARC-BSI Lumbar System.

13 secondary outcomes

10 Meters Walk Test (10MWT)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
6 Minutes Walk Test (6MWT)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Timed Up and Go (TUG)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Berg Balance Scale (BBS)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Neuromuscular Recovery Scale (NRS)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
EMG-based Gait Analysis
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Kinematics-based Gait Analysis
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Presence of visible movements during single joints movements attempts, measured in angular displacement of the joint (degrees, °)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Spasticity assessment (Modified Ashworth Scale - MAS)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
ASIA impairment scale - International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).
Somato-Sensory Evoked Potential (SSEP)
Time frame: Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

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 28 Jul 2026.
Background: PubMed 30382197Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
Background: PubMed 30068906Bonizzato M, Pidpruzhnykova G, DiGiovanna J, Shkorbatova P, Pavlova N, Micera S, Courtine G. Brain-controlled modulation of spinal circuits improves recovery from spinal cord injury. Nat Commun. 2018 Aug 1;9(1):3015. doi: 10.1038/s41467-018-05282-6.
Background: PubMed 24305828Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013.
Background: PubMed 37225984Lorach H, Galvez A, Spagnolo V, Martel F, Karakas S, Intering N, Vat M, Faivre O, Harte C, Komi S, Ravier J, Collin T, Coquoz L, Sakr I, Baaklini E, Hernandez-Charpak SD, Dumont G, Buschman R, Buse N, Denison T, van Nes I, Asboth L, Watrin A, Struber L, Sauter-Starace F, Langar L, Auboiroux V, Carda S, Chabardes S, Aksenova T, Demesmaeker R, Charvet G, Bloch J, Courtine G. Walking naturally after spinal cord injury using a brain-spine interface. Nature. 2023 Jun;618(7963):126-133. doi: 10.1038/s41586-023-06094-5. Epub 2023 May 24.
Background: PubMed 31587955Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Moriniere B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.
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. This study is not recruiting at the moment.

Jocelyne Bloch, MD principal investigator

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 ARC-BSI Lumbar system in people with Spinal Cord Injuries and Paraplegia, 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 12 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preliminary safety (time frame: Through study completion (implantation up to end of study - average of 1 year)). 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 NCT06243952, 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 28 Jul 2026.