Restoring hand function for people with cervical spinal cord injury

Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury

This study is testing a new device that helps people with cervical spinal cord injuries regain hand function by stimulating their muscles to see if it improves their ability to grip and manipulate objects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MetroHealth Medical Center (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06611748 on ClinicalTrials.gov

What this trial studies

This study evaluates a new method to restore hand function in individuals with cervical spinal cord injuries using an implantable device called the KeyGrip System. The device, which is based on the Nalu Medical Peripheral Nerve Stimulator, activates paralyzed muscles through low levels of electrical current. The study aims to assess the grasp strength and ability to manipulate objects achieved with this device. Participants must be at least six months post-injury and meet specific neurological and musculoskeletal stability criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with cervical spinal cord injuries classified as AIS grade A, B, or C and who are neurologically stable.

Not a fit: Patients with acute spinal cord injuries or those who do not meet the neurological stability criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve hand function and quality of life for patients with cervical spinal cord injuries.

How similar studies have performed: While similar approaches have been explored, the specific use of the KeyGrip System for restoring hand function in cervical spinal cord injury is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Megan Moynahan — MetroHealth Medical Center
• Study coordinator: Kim Walsh, OTR/L

Conditions Spinal Cord Injury Cervical; Cervical Spinal Cord Injury