Restoration of Hand Function in Cervical SCI

Launched by METROHEALTH MEDICAL CENTER · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to help people with cervical spinal cord injuries regain hand function. The study will look at a device called KeyGrip, which is a small implant that uses low electrical currents to stimulate and activate paralyzed hand muscles. This method is still being tested and is not yet approved by the FDA, but researchers are hopeful it could improve grasp strength for individuals who have lost this ability due to their injuries.

To be eligible for the trial, participants must be adults aged 18 and older with a cervical spinal cord injury classified as C1 through C7. They should be at least six months post-injury and show some muscle function in their arms. Participants will need to be medically stable and able to understand the study to give their consent. The trial is not currently recruiting, but once it begins, participants can expect to be closely monitored and evaluated to see how well the KeyGrip device works in restoring their hand function.

Gender

ALL

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