Status:
RECRUITING
Restoration of Hand Function in Cervical SCI
Lead Sponsor:
MetroHealth Medical Center
Conditions:
Spinal Cord Injury Cervical
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate a new method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers and nerve transfer...
Detailed Description
The purpose of this study is to evaluate an alternative method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers (surgery ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06611748
Start Date
January 1 2025
End Date
November 1 2030
Last Update
September 30 2025
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109