New implant could help paralyzed patients grasp and reach again
NCT ID NCT02329652
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a fully implanted neuroprosthetic device designed to improve hand, reach, and trunk function in people with cervical spinal cord injuries. Thirty participants will receive the device and be evaluated on their ability to perform daily activities with and without it. The goal is to restore independence in tasks like eating and dressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- implanted networked neuroprosthetic device
- What this could lead to
- If successful, this device could help people with spinal cord injuries regain the ability to perform daily tasks like eating and dressing independently.
- What could go wrong
- This is an early-stage study with only 30 participants, so results may not apply to everyone. The device requires surgery and may carry risks like infection or device malfunction.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2014
- Expected to finish
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Dec 2031
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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17 years and older
- 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: * Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury * Biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test * Peripheral nerve innervation to upper extremity and trunk muscles, including a grade 3/5 or higher stimulated strength (Manual Muscle Test) in at least two of the following muscles in one arm: adductor pollicis, abductor pollicis brevis, flexor pollicis longus, extensor pollicis longus, extensor digitorum communis, flexor digitorum superficialis, flexor digitorum profundus, pronator quadratus, extensor carpi ulnaris, extensor carpi radialis brevis, extensor radialis longus, flexor carpi ulnaris, flexor carpi radialis, first dorsal interosseous; and in at least two of the following muscles: left/right gluteus maximus, left/right erector spinae, left/right quadratus lumborum, * Age \> 16 years * Medically stable - cleared for surgery * Able and willing to take part in study Exclusion Criteria: * Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant) * Other neurological conditions (multiple sclerosis, diabetes with peripheral nerve involvement) * History of coagulopathy, HIV, severe cardiopulmonary disease, severe bradycardia, severe autonomic dysreflexia, or chronic obstructive pulmonary disease. * Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia * Presence of other active implantable medical devices with unknown or untested interaction with the NNP implant * Active implantable medical device (AIMD) such as a pacemaker or defibrillator, with the exception of the implanted stimulator-telemeter (IST) or implanted receiver stimulator (IRS) systems developed by the Cleveland Functional Electrical Stimulation Center * Unhealed fractures that prevent functional use of arm or trunk * Less than six months post-injury (neuroprosthesis implantation delayed until criteria met) * Extensive upper extremity denervation (fewer than two stimulatable hand muscles and two stimulatable trunk muscles) * Involvement in other ongoing clinical studies that exclude concurrent until criteria met) * Disorder or condition that require MRI monitoring * Mechanical ventilator dependency * Progressive SCI In subjects who are undergoing bilateral implantation, subjects should not have a history of autonomic dysreflexia, hypertension, diabetes or any condition which requires frequent blood pressure monitoring or frequent venipuncture. * Adverse interaction between system components and typical electromagnetic (EM) sources in subject's home and work environments, including wheelchair or other active implantable devices.
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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. 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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MetroHealth Medical Center
RECRUITINGCleveland, Ohio, 44109, 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?