Spinal Cord Stimulation

The Center for Neurotechnology listed nine new papers spanning experimental and computational neuroscience, neural interfaces and neuroethics. The selection includes Smart Dura for multimodal neural recording and modulation, work on transcutaneous spinal-stimulation trials, primate optogenetics, co-adaptive interfaces, motor-cortex activity and participatory neuroethics research.

Ecole Polytechnique Fédérale de Lausanne (EPFL) has launched a clinical study evaluating the preliminary safety and effectiveness of a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) to restore voluntary lower-limb motor function in participants with chronic spinal cord injury and mobility impairment. The study aims to establish a direct bridge between motor intention and the spinal cord below the lesion, potentially improving or restoring voluntary leg control and promoting neurological recovery when combined with neurorehabilitation.

The FDA approved a premarket approval (PMA) supplement, S039, from Saluda Medical Pty, Ltd. on June 29, 2026, covering the CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA) and RECAP Viewer. The supplement is a labeling change touching indications, instructions for use, shelf life and trade name rather than an original approval of a new device; the products carry the generic name 'stimulator, spinal-cord, totally implanted for pain relief.' Saluda Medical is an Australian company whose Evoke system is one of the few closed-loop spinal cord stimulators on the market.

Women with overactive bladder often rely on drugs and behavioral training, with limited relief. A newly registered trial at The First Affiliated Hospital of Soochow University takes a different route: patients perform a task while functional near-infrared spectroscopy reads prefrontal brain activity, and an algorithm decides when to deliver transcranial magnetic stimulation, closing the loop. The interventional, parallel-design trial plans to enroll 66 women aged 18 to 75, 33 in the experimental arm and 33 in a control arm that receives open-loop sham stimulation, with the overactive bladder symptom score as the primary endpoint. No device model or results are disclosed in the registration, and recruitment has not yet started.

Onward Medical said the first participant in its global Empower BP pivotal study was enrolled and implanted with the investigational ARC-IM system at Craig Hospital in Denver during the first quarter of 2026. The randomized, double-blind, sham-controlled trial is evaluating management of blood-pressure instability after spinal cord injury across about 20 planned centers. Empower BP is not an upper-limb BCI trial, and the first implant did not take place in the Netherlands.

Can a non-invasive brain-computer interface read motor intention and, combined with spinal cord stimulation and exoskeleton training, improve function after spinal cord injury? Xuanwu Hospital, Capital Medical University has registered a single-arm exploratory trial that plans to enroll 10 patients aged 18 to 65 with spinal cord injury. The intervention combines all three into one rehabilitation regimen. The primary outcome is the overall clinical efficacy rate 6 months after surgery; secondary outcomes include improvement in the Visual Analogue Scale for pain and the incidence of adverse events related to the trial devices.

ARC-EX is a non-invasive spinal cord stimulation device used to improve hand function in people with spinal cord injury; the CE mark allows commercial sale in the EU.

The University of Miami has opened a clinical trial testing whether a brain-computer interface can decode upper-limb motor intention from EEG or ECoG and use it both to trigger epidural spinal cord stimulation (ESCS) and to control assistive devices in people with spinal cord injury. The study was first posted on August 1, 2024, and is recruiting.

The University of Miami is recruiting participants with incomplete spinal cord injury for a walking rehabilitation trial combining a brain-computer interface with transcutaneous spinal cord stimulation. The trial is registered on ClinicalTrials.gov as NCT06406855 and is currently recruiting.