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

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 trial evaluates the safety and effectiveness of the Networked Neuroprosthesis Device for individuals with cervical spinal cord injuries. The device aims to restore hand and reaching functions by activating peripheral nerves to enable movement in paralyzed muscles. Participants will be assessed on their ability to grasp and release objects using the device, which senses voluntary motion and electromyographic signals. The study focuses on individuals who have been stable for at least six months post-injury and have some remaining muscle function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, age \> 16 years.
* Cervical level spinal cord injury, as defined by:

  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor level of C1 through C7 and
  2. American Spinal Injury Association (ASIA) 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).
* Peripheral nerve innervation to upper extremity muscles, including a grade 3/5 or higher Stimulated Manual Muscle Test (SMMT) strength in at least two of the following muscles in one arm:

  1. Adductor Pollicus, Abductor Pollicus Brevis (AbPB), Flexor Pollicus Longus (FPL), Extensor Pollicus Longus (EPL)/Extensor Pollicus Brevis (EPB), Extensor Digitorum Communis (EDC), Flexor Digitorum Superficialis (FDS), Flexor Digitorum Profundus (FDP), Pronator Quadratus (PQ), Extensor Carpi Ulnaris (ECU), Extensor Carpi Radialis Brevis (ECRB), Extensor Carpi Radialis Longus (ECRL), Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), First Dorsal Interosseous(1DI), triceps,
  2. At least two of the grade 3/5 or higher excitable muscles must also have grade 2/5 or lower voluntary strength;
* Good proximal upper extremity strength as defined by biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test on the side intended for implantation;
* Medically stable;
* Able to understand and provide informed consent.

Exclusion Criteria:

* Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheral nerve involvement); Associated peripheral nerve / brachial plexus injury
* Progressive SCI;
* Co-existing cervical spine pathology (syrinx, unstable segment)
* Active implantable medical device (AIMD) such as a pacemaker or defibrillator;
* Active untreated infection such as pressure injury, urinary tract infection, pneumonia;
* 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;
* Disorder or condition that requires MRI monitoring;
* Mechanical ventilator dependency;
* Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant);
* 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.

Where it's running

• MetroHealth Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Anne Bryden, PhD, OTR/L — MetroHealth Medical Center
• Study coordinator: KIm Walsh, OTR/L
• Email: kwalsh3@metrohealth.org
• Phone: 216-957-3512

Similar studies

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

• Neuroprosthetic system to restore motor function in spinal cord injury

  This study is testing a new implanted device to see if it can help people with cervical spinal cord injuries regain hand function and improve their ability to move and be independent.

  Recruiting MetroHealth Medical Center · Cleveland, Ohio · NCT02329652

• 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

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  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.