Neuroprosthetic system to restore motor function in spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a fully implanted neuroprosthetic device designed to restore hand function, reach, and trunk mobility in individuals with cervical spinal cord injuries. The approach encompasses the surgical installation of the device and a coordinated assessment of outcomes to enhance functional independence. By targeting multiple functions such as grasp, reach, and posture, the study aims to improve the overall quality of life for participants. The research builds on 30 years of advancements in neuroprosthetic systems for spinal cord injury patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• MetroHealth Medical Center
  Cleveland, Ohio, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessment of a neuroprosthesis device for hand function in spinal cord injury patients

  This study is testing a new device that helps people with cervical spinal cord injuries regain hand movement to see if it can improve their ability to grasp and release objects.

  Recruiting MetroHealth Medical Center · Cleveland, Ohio · NCT05863754

• Improving arm and hand recovery after spinal cord injury using therapy and stimulation

  This study is testing if combining special therapy with spinal cord stimulation can help people with cervical spinal cord injuries recover better use of their arms and hands.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT06472986

• Testing spinal stimulation methods for improving motor function in spinal cord injury patients

  This study is testing different spinal stimulation methods to see if they can help improve movement in people with spinal cord injuries at the C5-C7 level.

  Recruiting University of Manitoba · Winnipeg, Manitoba and 1 other locations · NCT06272279

• Restoring hand and wrist function in people with tetraplegia using a neural device

  This study is testing a new device to see if it can help people with tetraplegia regain movement and feeling in their hands and wrists.

  Recruiting Northwell Health · Manhasset, New York · NCT03680872

• Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury

  This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.

  Recruiting TryAbility LLC · Downers Grove, Illinois · NCT07922122

• Electrical stimulation for arm function after cervical spinal cord injury in veterans

  In veterans with a recent cervical spinal cord injury, researchers are testing whether transcutaneous spinal stimulation (TSS) can improve arm and hand function more than the standard functional electrical stimulation (FES) during inpatient rehab.

  Recruiting Center for Veterans Research and Education · Minneapolis, Minnesota · NCT07911657

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.