Restoring hand function for people with cervical 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 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.

Why it matters

Who can join: the full rules

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 it's running

• MetroHealth Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Megan Moynahan — 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.

• 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

• Wireless implant for brain-computer interface in people with tetraplegia from spinal cord injury

  This trial tests a wireless brain-computer interface implanted in adults with tetraplegia to see if it is safe and if it can help restore some function.

  Recruiting BCIFlex Medical Technology Co., Ltd. · Beijing · NCT07784088

• Epidural spinal cord stimulation to help breathing after cervical spinal cord injury

  This trial tests whether adding epidural spinal cord stimulation to standard care can improve breathing in adults with cervical spinal cord injury and respiratory failure.

  Recruiting at 2 sites Zhongda Hospital · Nanjing, Jiangsu and 1 other locations · NCT07722130

• Optimizing sensory feedback to maximize hand and arm function after tetraplegia

  This project tests different patterns of brain and nerve electrical stimulation to restore touch and pressure sensations in people with cervical spinal cord injuries who already have ReHAB implants.

  Recruiting Case Western Reserve University · Cleveland, Ohio · NCT07225582

• Non-invasive breathing therapies to improve respiratory function after chronic spinal cord injury

  We will try combining non-invasive spinal electrical stimulation and brief high-carbon-dioxide breathing with respiratory resistance exercises to see if they improve breathing in adults with chronic incomplete spinal cord injury.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07135583

• Using brain-computer interface technology to improve walking in spinal cord injury patients

  This study is testing a new brain-computer interface system to see if it can help people with spinal cord injuries walk better and improve their quality of life.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT06939660

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.