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Tiny implant aims to restore hand grip after spinal cord injury
NCT ID NCT06611748
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a small device called KeyGrip that is implanted in the arm to help people with cervical spinal cord injury regain hand function. The device uses mild electrical pulses to activate paralyzed muscles, allowing hand opening and closing. Researchers will measure grip strength and the ability to pick up everyday objects in 20 adults who are at least six months post-injury.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KeyGrip implantable peripheral nerve stimulator
- What this could lead to
- If successful, this could provide a new way to restore hand function for people with spinal cord injury, improving daily tasks like grasping objects.
- What could go wrong
- This is an early feasibility study with only 20 participants, so results may not apply to everyone. The device is investigational and not yet FDA-approved.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Nov 2030
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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18 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: * Male or female adults 18 years of age or older; * Cervical spinal cord injury as defined by: a) International Standard for Neurological Classification of Spinal Cord Injury motor level of C1 through C7; and b) American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C; * Six months or more post-injury (neurostability); * Neurologically stable following any nerve transfers affecting the upper extremity (typically, one-year post-surgery); * Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity (typically 6 months post-surgery). * Peripheral nerve innervation to upper extremity muscles, including Grade 3/5 or higher Stimulated Manual Muscle Testin at least two of the muscles in one arm: * Good proximal voluntary upper extremity strength as defined by biceps/ brachialis / brachioradialis strength of 2/5 or higher on Manual Muscle Testing the side intended for implantation; * Medically stable; and * Able to understand and provide informed consent; Exclusion Criteria: * Other neurological conditions (Multiple Sclerosis, diabetes with peripheral nerve involvement); * Associated peripheral nerve / brachial plexus injury; * Progressive Spinal Cord Injury; * Active implantable medical device (AIMD) such as a pacemaker or defibrillator; * Active untreated infection such as urinary tract infection or pneumonia; * Active pressure injury; * History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, poorly controlled autonomic dysreflexia, or chronic obstructive pulmonary disease that would preclude safe participation in the trial as determined by the investigator; * Unhealed fractures that prevent functional use of arm; * Extensive upper extremity denervation (fewer than two excitable hand muscles); * Involvement in other ongoing clinical studies that exclude concurrent involvement in this study; * Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant based on self-report); Urine or serum testing will happen during the pre-surgery evaluation. * Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study; * Other significant medical findings that, in the opinion of the investigator, preclude safe participation in the trial
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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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MetroHealth Medical Center
RECRUITINGCleveland, Ohio, 44109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can magnetic pulses to the brain restore hand control after spinal injury?
- Spinal zaps may calm muscle spasms after injury
- Spinal stimulation may unlock better hand control after injury
- Mind over matter: can a wireless brain implant restore control for the paralyzed?
- Spinal cord zap may help people breathe again after neck injury
- Hands-Free faucet gives independence back to spinal cord injury patients