Washington University School of Medicine in St. Louis is launching a multi-center clinical trial assessing whether the surgical rerouting of nerves can restore hand and arm function in people who have suffered spinal cord injuries in their necks. Apparently, some small-scale studies have evidenced good to excellent results in many surgically treated patients.
The Problem: Spinal Cord Injuries
Over 5,000 Americans each year unfortunately get spinal cord injuries—caused by accidents, violence and disease—attacking the neck down, and many will never walk again. In the first few months after surgery, some people may regain some movement and sensation in their limbs but those less unfortunate don’t show improvement and, hence, are unlikely to recover.
What if a Patient Could get Their Hand and Arm Back?
The Telegraph reports that Dr. Wilson “Zack” Ray, associate professor of neurosurgery, biomedical engineering and orthopedic surgery at Washington University, noted, that if patients with Quadriplegia—paralysis of both the arms and the legs—had a choice of what function to get back “they’ll tell you hand and arm function.” Why? “It’s more important to many than bladder and bowel control, sexual function or walking,” commented Dr. Ray. He continued, “If you have control over your arms and hands, you can get into and out of a wheelchair by yourself, use a cell phone, feed yourself. It gives them a measure of independence. Not everyone who has had the surgery has regained these abilities, but some have.”
Sponsored by Washington University in collaboration with a group of other research centers, the study sponsors share that current treatments of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life and long-term functional independence will provide a significant public health impact. The sponsor and collaborators specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and functional independence.
Dr. Ray notes that in their Phase I trial (before this present one), “some people had very profound, dramatic improvements and did very well, and others had very minimal functional improvements that didn’t add to their independence.” Dr. Ray further explained that “What we hope to do with this Phase II trial is to determine who is most likely to benefit from this procedure.”
The study seeks to enroll 70 people who were paralyzed by a spinal cord injury in the neck within the last three years, and have seen no improvement in their abilities in the past three months, reports The Telegraph.
During this clinical trial, each patient will undergo a surgery to attack a nerve from above the site of injury to nerves below the site of injury that connect to muscles in the hands and arms. The patients then will participate in regulatory physical therapy for the next two years, reports The Telegraph. The researchers will thereafter assess and measure the participant’s ability to extend and turn their arms and grip their hands. The investigators seek data from a larger group of surgery patients in the hopes of identifying the optimal time post injury to perform the procedure as well as better understand which kinds of injuries are most suited for this kind of surgery. Other factors are considered that impact the gain of arm and hand function.
The study is being funded by a $3.5 million grant from the U.S. Department of Defense.
The clinical trial is sponsored by Washington University and includes collaborators such as Stanford University, University of Utah, University of Michigan, University of Calgary, University of Pennsylvania and University of Texas. It was determined that no single site would have sufficient numbers of patients.
Wilson Z. Ray, Washington University School of Medicine
Call to Action: If you have a loved one that meets this inclusion criteria and has lost all movement function, this could be a procedure to consider.