United States

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.

Colorado's HB24-1058, signed in 2024, brought neural data under the state privacy act's sensitive-data protections, a first in the United States.

A randomized clinical trial called BCI-REHAB compared an at-home brain-computer interface (BCI) therapy system with a home exercise program for upper-extremity rehabilitation in chronic stroke survivors. The trial, conducted in the United States, was first posted on July 28, 2023, last updated on August 12, 2026, and has a status of completed. The study used Neurolutions' IpsiHand Upper Extremity Rehabilitation System, which reads motor intentions via scalp electrodes and drives an exoskeleton hand device to facilitate repetitive hand movement training. The trial aimed to evaluate the efficacy of BCI-based therapy versus standard exercise therapy and assess the potential for meaningful motor improvement in a home setting. The trial covered conditions including stroke, hemiparesis, spasticity as a sequela of stroke, and chronic stroke survivors with a plegic hand, but results have not yet been published.

The University of Texas at Austin has registered a study on ClinicalTrials.gov, NCT05907343, testing whether non-invasive stimulation can strengthen cognitive control in older adults, enrolling both people with cognitive impairment and people without it. It asks whether theta burst stimulation, a form of transcranial magnetic stimulation, can restore a range of cognitive functions, and whether delivering it in closed loop, timed to ongoing brain activity rather than on a fixed schedule, changes the result.

The US Bureau of Industry and Security announced a two-day hybrid BCI conference with industry and academic experts, following its 2021 export-control inquiry.

The FDA granted Breakthrough Device designation to Blackrock Neurotech's MoveAgain BCI System on November 16, 2021. The investigational system combines an implanted array, neural decoding and wireless output with the goal of allowing people with severe paralysis to control digital and assistive devices. The designation can expedite development and review but is not market approval.

The US Bureau of Industry and Security published a 2021 advance notice seeking comments on export controls for BCI as an emerging technology, focused on national security.

The VA Office of Research and Development is conducting a clinical trial to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation and to develop advanced controllers for moving a prosthesis. The trial uses Functional Electrical Stimulation (FES), applying small electric currents to the nerves, and tests different stimulation placements. The trial is registered as NCT04947462 and is currently recruiting.

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

Vanderbilt University Medical Center has developed a method that uses post-operative CT scans and image processing to determine the physical relationship between cochlear implant electrodes and the neural interface, allowing sub-optimally positioned electrodes to be switched off for a customized map. Cochlear implants are surgically implanted devices that restore hearing by electrically stimulating the auditory nerve, and their programming has traditionally ignored where the electrodes actually sit. The trial tested whether this individualized image-guided programming improves hearing and speech outcomes in pediatric recipients, with hearing measures collected at baseline, 12 months and 24 months; it has been completed, but results have not been posted.

Johns Hopkins University is conducting an early feasibility study to evaluate the safety and efficacy of the Bidirectional Cortical Neuroprosthetic System (BiCNS). The system comprises NeuroPort Microelectrode Array Systems, NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The trial enrolls patients with tetraplegia and quadriplegia and is currently recruiting.