Spinal cord stimulation for paralysis

Also known as Epidural spinal cord stimulation, Epidural electrical stimulation (EES), Transcutaneous spinal cord stimulation, ARCEX Therapy

Electrical stimulation of the spinal cord can help some people with spinal cord injury move again. Implanted epidural systems have restored walking and trunk control in very small research cohorts. A non-invasive system called ARCEX was studied in a 65-person trial, and its maker states that it is FDA cleared to improve hand sensation and strength in people with incomplete cervical spinal cord injuries.

Pilot and early commercialDemonstratedReviewed 21 Oct 2026
AI illustration · Illustrative scene, not a photograph of the specific device or experiment.

In plain language

After a spinal cord injury, the nerves below the injury can still work, but the signals from the brain no longer reach them reliably. Spinal cord stimulation sends small electrical pulses to the lower back or neck to make the nerves that control the legs, trunk, or arms easier to switch on. When the stimulation is timed to a person's own attempts to move, researchers think the spinal circuits may carry more of the work, and some people regain movement that they did not have before.

There are two main approaches. Epidural systems place electrodes surgically on the surface of the spinal cord or its nerve roots, which gives precise control but needs an implant. Transcutaneous systems place electrodes on the skin over the spine and need no surgery, though the signal is less focused. Early results in very small groups look encouraging, but the effects vary between people and the long-term benefit is still being studied.

Technical explanation

Epidural stimulation delivers current through multi-contact paddle leads placed over the dorsal roots or dorsal columns at lumbosacral or cervical levels. Rowald and colleagues (2022) tested a new paddle lead designed to target the dorsal roots that control leg and trunk movement, with its placement guided by computational modelling. In three people with complete sensorimotor paralysis, activity-specific stimulation programmes enabled standing, walking, cycling, swimming and trunk control within a single day. Wagner and colleagues (2018) used an implanted pulse generator that delivered stimulation timed to intended movement, in people with chronic spinal cord injury who had been injured more than four years earlier. Press coverage reports three participants, and describes voluntary control of previously paralysed muscles improving over about five months of training and persisting when stimulation was switched off.

Transcutaneous stimulation applies surface electrodes over the spine. The Up-LIFT trial (Moritz and colleagues, 2024) studied ARCEX Therapy, a non-invasive system designed to improve arm and hand function in chronic tetraplegia. It was a single-arm, open-label study with 65 enrolled participants and 60 in the primary effectiveness analysis. The authors report that 43 of 60 participants (71.7%) met the criteria for responders in both strength and function, and that this met the primary effectiveness endpoint. No serious adverse events were judged related to the therapy. The design had no concurrent control group and no sham stimulation, so the size of the effect compared with rehabilitation alone is uncertain.

What the evidence says

Each statement is typed by the strength of its evidence and linked to the source that supports it.

Demonstrated Shown in a published experiment, test or shipping product.

In the single-arm, open-label Up-LIFT trial of 60 analysed participants with chronic tetraplegia, 43 (71.7%) met responder criteria for both strength and function, and the trial met its primary effectiveness endpoint.

Sources: [1], [5] · Results, primary endpoints

In the Up-LIFT trial, 54 participants (90%) met the criteria for at least one strength or function outcome. The study had no concurrent control group and no sham stimulation.

Sources: [1] · Results; Discussion

In the Up-LIFT trial, no serious adverse events were judged related to ARCEX Therapy or study procedures. Of 64 participants in the safety population, 17 (26.6%) had related non-serious adverse events, and one severe event (muscle spasms) was judged unrelated.

Sources: [1] · Safety results; Table 3

Rowald and colleagues used a new epidural paddle lead to deliver stimulation to dorsal roots, and in three people with complete sensorimotor paralysis, activity-specific programmes enabled standing, walking, cycling, swimming and trunk control within a single day.

Sources: [2] · Abstract

Reported, unverified Stated by a company or team but not independently confirmed.

In press coverage of Wagner and colleagues (2018), three people with chronic spinal cord injury regained voluntary control of previously paralysed muscles over about five months of training, and the gain persisted when stimulation was switched off.

Sources: [4], [3] · Press coverage of Wagner and colleagues (2018); abstract for the general finding · medium confidence

ONWARD Medical states that ARCEX is FDA cleared for use in the United States for people aged 18 to 75 with chronic, non-progressive incomplete spinal cord injury at C2 to C8, to improve hand sensation and strength.

Sources: [6] · Product page, US indication for use · medium confidence

ONWARD Medical announced on 2 April 2024 that it had submitted a De Novo application to the FDA for the ARC-EX system, with upper-limb function as the first indication, following the Up-LIFT trial.

Sources: [5] · Article body · medium confidence

ONWARD Medical states that its non-invasive system is CE marked under EU Medical Device Regulation 2017/745, and that the EU indication is nearly identical to the US one. The product page lists the United States, Europe and Israel as locations, but gives regulatory status only for the US and EU.

Sources: [6] · Product page, regulatory status and location selector · medium confidence

Limitations and open problems

  • The Up-LIFT trial was single-arm and open-label with no sham group, so the gains cannot be fully separated from rehabilitation alone (Moritz and colleagues, 2024).
  • The authors cannot exclude that the rehabilitation period before stimulation alone improved responses, and the therapy period was a pre-specified two months, so the trial does not show how long the benefit lasts (Moritz and colleagues, 2024).
  • Epidural results come from very small groups of three participants each, so they cannot yet show how well the approach works across the wider spinal cord injury population (Rowald and colleagues, 2022; Wagner and colleagues, 2018).
  • The authors state that the mechanisms behind the improvements still need to be explored (Moritz and colleagues, 2024).
  • The Up-LIFT trial was sponsored by ONWARD Medical, and several investigators hold patents, act as consultants to the company or may hold shares in it (Moritz and colleagues, 2024).
  • The company states that the non-invasive system is cleared for incomplete injuries only, and the sources reviewed did not identify a comparable clearance for complete injuries.

Possible future uses

Speculative

Ideas, not predictions. None of these has been demonstrated.

  • Non-invasive stimulation as a home-based adjunct to physiotherapy for people with incomplete spinal cord injury.
  • Closed-loop systems that adjust stimulation in real time to a person's movement intentions.
  • Extension of spinal stimulation to trunk and bladder control in people with complete paralysis.

Product concepts: Neural bypass for hand function after injury

Timeline

  1. 31 Oct 2018Wagner and colleagues report in Nature that stimulation timed to intended movement restores walking in people with chronic spinal cord injury. Sources: [3], [4]
  2. 7 Feb 2022Rowald and colleagues report in Nature Medicine that a new epidural lead restored trunk and leg control in three people with complete paralysis. Sources: [2]
  3. 2 Apr 2024ONWARD Medical announces that it has submitted a De Novo application to the FDA for the ARC-EX system, with upper-limb function as the first indication. Sources: [5]
  4. 20 May 2024Moritz and colleagues publish the Up-LIFT pivotal trial of non-invasive spinal cord stimulation for arm and hand function in Nature Medicine. Sources: [1]

Futures this could help bring about

Related breakthroughs

Glossary

Epidural stimulation
Electrical stimulation delivered by electrodes placed on the outer surface of the spinal cord or nerve roots, inside the spinal canal.
Transcutaneous stimulation
Electrical stimulation delivered through electrodes placed on the skin, without surgery.
Tetraplegia
Partial or complete paralysis of the arms, trunk and legs, caused by injury to the cervical (neck-level) spinal cord.
Responder (Up-LIFT)
A participant who met the Up-LIFT responder criteria for both strength and function.

Sources

  1. peer reviewed paper
    Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial
    Chet Moritz, Edelle C. Field-Fote, Candace Tefertiller et al.. Nature Medicine, 20 May 2024. DOI: 10.1038/s41591-024-02940-9. Accessed 21 Oct 2026.
  2. peer reviewed paper
    Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis
    Andreas Rowald, Salif Komi, Robin Demesmaeker. Nature Medicine, 7 Feb 2022. DOI: 10.1038/s41591-021-01663-5. Accessed 21 Oct 2026.
  3. peer reviewed paper
    Targeted neurotechnology restores walking in humans with spinal cord injury
    Fabien B. Wagner, Jean-Baptiste Mignardot, Camille G. Le Goff-Mignardot et al.. Nature, 31 Oct 2018. DOI: 10.1038/s41586-018-0649-2. Accessed 21 Oct 2026.
  4. news
    Breakthrough in treating paralysis
    ScienceDaily, 1 Nov 2018. Accessed 21 Oct 2026.
  5. news
    ONWARD Medical Submits De Novo Application to FDA for its ARC-EX System
    Santelog, 2 Apr 2024. Accessed 21 Oct 2026.
  6. company announcement
    ARC-EX (ARCEX System) product information
    ONWARD Medical, 21 Oct 2026. Accessed 21 Oct 2026.

Revision history

3 changes since this profile was created.

Changes on 21 Oct 2026
Published on owner instruction (content loop iteration 6)2124aeb
Sources and claims re-checked against originalsfbb434c
Initial profile drafted from primary sources7e66249