Brain bypass device aims to give hand control back to paralyzed patients
NCT ID NCT03680872
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a device called the Bidirectional Neural Bypass System in up to 7 people with tetraplegia (paralysis from the neck down). The device is designed to let users move and feel their hand and wrist again by bypassing the damaged spinal cord. Researchers will measure improvements in movement and sensation during lab sessions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bidirectional Neural Bypass System (implantable device)
- What this could lead to
- If successful, this device could help people with paralysis regain some hand movement and feeling, improving daily independence.
- What could go wrong
- This is a very early, small study with only 7 participants. The device is experimental and may not work for everyone, and risks from surgery or device use are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 7 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females between 22 and 65 years of age 2. Individuals with a stable cervical spinal cord injury that have International Standards for the Neurological Classification of SCI (ISNCSCI) motor scores for fingers of 0 - 2 (non-functional) and ISNCSCI sensory scores of 0 - 2 (not normal) on the palmar side 3. Individuals at least one year from initial spinal cord injury 4. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions 5. Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation. 6. Individuals that are willing and able to visit the study center for study procedures that will be 1-3 sessions a week for up to 48 months at 1-4 hours per session. 7. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies 8. Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb Exclusion Criteria: 1. Individuals participating in another research study that may affect the conduct or results of this study 2. Individuals having or exhibiting any of the following: 1. Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries 2. Prior difficulties or allergy to general anesthesia 3. Active wound healing or skin breakdown issues 4. Stage III-IV pressure ulcers 5. Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other) 6. Prior tendon transfer to enhance hand function 7. History of autoimmune disease 8. Cancer 9. Biochemical abnormalities of the liver, kidney, or pancreas 10. Ventilator dependence 11. History of serious mood or thought disorder 12. Significant residual clinically evident traumatic brain injury or cognitive impairment 13. Uncontrolled autonomic dysreflexia 14. Spasticity in the upper extremities that is uncontrolled by pharmacological methods 15. Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months 16. Individuals with any type of destruction and/or damage to the motor cortex region as determined by fMRI. 17. History of a neurological ablation procedure 18. History of hemorrhagic stroke 19. History of infectious or chronic diseases, such as HIV or tuberculosis 3. Individuals with any of the following co-morbid conditions that would interfere with study activities or response to treatment: 1. Life expectancy \< 3 years 2. Severe chronic pulmonary disease 3. Intractable seizure disorders 4. Local, systemic acute or chronic infectious illness 5. Life threatening cardiac arrhythmias 6. Severe collagen vascular disorder 7. Kidney failure or other major organ systems failures 4. Individuals with a substance abuse (alcoholism or other) problem 5. Pregnant women 6. Prisoners
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwell Health's The Feinstein Institute for Medical Research
RECRUITINGManhasset, New York, 11030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?