Spinal cord injury (SCI) affects millions worldwide, with over half of all cases resulting in tetraplegia, where a complete injury can cause profound motor and sensory loss in all four limbs1. Here, we demonstrate an artificial ‘double neural bypass’ (DNB) that integrates a bidirectional intracortical brain-computer interface with targeted spinal and brain stimulation to promote restoration of upper limb function in severe, complete paralysis. This hybrid assistive-therapeutic approach restores both hand movement and tactile sensation simultaneously via cortical mediation while promoting significant persistent sensorimotor improvements. The DNB uses a stable nested neural decoding architecture with deep reinforcement learning for fine grasping, along with patterned brain microstimulation (‘cortical mirroring’) and spinal cord stimulation to promote real-time and long-term functional recovery. Using the DNB, our participant with chronic C4 sensory/C5 motor complete tetraplegia regained the ability to self-feed, grasp delicate objects, and experienced persistent recovery of arm flexion and wrist tactile sensation. These findings represent a major advance in restoring meaningful function after severe, complete SCI, demonstrating that bidirectional neuroprostheses combined with targeted brain and spinal neuromodulation can drive durable sensorimotor recovery and improve independence and quality of life.
Competing Interest StatementCEB has financial interests in Neuvotion, Inc, a medical device company developing neurotechnologies for restoring function after stroke or spinal cord injury, and Sanguistat, LLC, a company developing neurostimulation technologies to reduce blood loss; he also has multiple patents in the field of neuroprosthetics and related fields. The remaining authors declare no competing interests.
Clinical TrialThe study is registered at ClinicalTrials.gov (NCT03680872) and was conducted under an Investigational Device Exemption (IDE G170200) issued by the US Food and Drug Administration (FDA).
Funding StatementThis study was funded by New York State Department of Health Spinal Cord Injury Research Board (Contract #C37718GG) and the Feinstein Institutes for Medical Research at Northwell Health with additional support from Blackrock Neurotech and Good Shepherd Rehabilitation Network.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The protocol was approved by the Northwell Health Institutional Review Board (IRB# 17-0840) and was in accordance with the Declaration of Helsinki. The participant provided written informed consent for study participation, and permission for the use of photos, along with audio and video recordings, in which he appears.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors
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