Invasive BCI

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 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 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.