The leadership group of the Texas Biomedical Devices Center includes, from the left, Dr. Michael Kilgard, Dr. Jane Wigginton, Dr. Seth Hays and Dr. Robert Rennaker.
In a new clinical study, the researchers at the Texas Biomedical Devices Center (TXBDC) of the University of Texas in Dallas demonstrated unprecedented recovery rates for spinal cord injuries.
In this study, published in the prestigious Nature Nature magazine on May 21, people with incomplete spinal cord injury safely received a combination of stimulation of a nerve in the neck with progressive and individualized rehabilitation. This approach, called closed vague circuit nerve stimulation (CLV), produced significant improvements in the arm and hand function in these individuals.
The unprecedented results position UT Dallas scientists to proceed with a fundamental essay: the final obstacle on the way to the possible approval of the Food and Medicines Administration (FDA) of the stimulation of the vagus nerve for the treatment of the deterioration of the upper limb due to the lesion of the spinal cord.
This approach is based on more than a decade of neuroscience and bioengineering efforts by UT Dallas researchers. The therapy uses electrical pulses sent to the brain through a small device implanted in the neck and timed to occur during rehabilitation exercises. The previous work of UT Dallas researchers has shown that stimulating the vagus nerve during physiotherapy can re -watered areas of the brain damaged by stroke and lead to better recovery.
Dr. Michael Kilgard, Margaret Fonde Jonsson’s neuroscience professor at the School of Behavior and Cerebral Sciences and corresponding author, explained that the treatment of spinal cord injury with CLV is different from the conditions directed in previous studies.
“In stroke, people who only make therapy can improve, and add Clv multiplies that improvement,” he said. “This study is different: the therapy alone for the spinal cord injury did not help our participants at all. It is really innovative that we are creating a gain where there would be any other way.”
“It is really innovative that we are creating a gain where there would be none otherwise.”
Dr. Michael Kilgard, Professor of Neuroscience at Margaret Fonde Jonsson at the School of Behavior and Brain Sciences
The trial involved 19 participants with chronic and incomplete injury of the cervical marrow. Each person made 12 weeks of therapy, playing simple video games to trigger specific movements of the upper extremities. The implant was activated in successful movements, which resulted in significant benefits for the strength of the arms and hands.
“These activities allow patients to recover strength, speed, movement range and manual function. They simplify daily life,” said Dr. Robert Rennaker, a professor of neuroscience and the distinguished Texas instruments in bioengineering, who designed the Clv device implanted in miniature.
The study served as a phase 1 clinical trial and phase 2 and included randomized placebo control in its first phase, in which nine of the 19 participants received simulated stimulation instead of active treatment during the first 18 therapy sessions, then received CLV in the last 18 sessions.
The participants were between 21 and 65 years old and were one to 45 years after the injury. None of these factors, nor the severity of deterioration in those with any movement of the hand, influenced the degree of response to treatment.
“This approach produces results regardless of these factors, which often cause significant differences in the success rates of other types of treatment,” said the study co -author, Dr. Jane Wigginton, doctor and medical director of TXBDC, co -director of the UTD Clinical and Translation Research Center, and Director of Medical Sciences Research in the center of Brainhealth.
“It is remarkable from the medical point of view,” said Wigginton, who planned the clinical interactions and patient protections for the trial.
TXBDC has worked to deal with a wide variety of conditions using CLV in 13 years of research. As a result, the FDA has approved the stimulation of the vago nerve to treat the movement of the upper limb deteriorated in patients with stroke.
Wigginton said the last results are especially exciting because they help people for whom there is no existing solution.
“I cannot emphasize too much how satisfactory it is as a doctor to give hope and help these patients with spinal cord injuries … people in this study have now gained the ability to do things that are significant for them and shocking in their lives.”
Dr. Jane Wigginton, doctor and medical director of the Texas Biomedical Devices Center
The most recent wireless version of the closed vague circuit nerve stimulation device is approximately the size of a ten cents.
“I cannot emphasize too much how satisfactory it is as a doctor to give hope and help these patients with spinal cord injuries, who would enter with all kinds of complications and hopelessness,” he said. “People in this study have now won the ability to do things that are significant for them and shocking in their lives.”
The newest generation of the implantable CLV device, designed by Rennaker, is approximately 50 times smaller than its version of three years ago. It does not prevent patients from receiving IRM, computerized or ultrasound tomographs.
A fundamental phase 3 trial will include 70 participants in multiple US institutions that specialize in spinal cord injuries.
Co -author Dr. Seth Hays, associate professor of Bioengineering and Companion, Eugene McDermott, a distinguished professor at the Erik Jonsson School of Engineering and Informatics, has been with the CLV project dating from the first studies.
“Before this study, no person with spinal cord injury had received CLV,” he said. “This is the first evidence that earnings can be obtained. Now we will establish us to determine how we will do it optimally.”
Hays warned that it is not an inevitable conclusion that therapy will reach patients after the next trial.
“We still have a long way ahead. For many reasons, financial, regulatory or scientific, this could still die in the vine,” he said. “But we have positioned ourselves to succeed.”
The research team emphasized the importance of dozens of people involved at work: both patients and TXBDC partners at Baylor University Medical Center, Baylor Scott & White Research Institute and Baylor Scott & White Institute for Rehabilitation.
“This has been the most hardworking and altruistic group of professionals, and that has been incredibly shocking,” Wigginton said.
By pointing out that even outpatient surgery is complex for those with deteriorated mobility, Rennaker added: “These patients said: ‘put that device in me’, that is a great commitment. They deserve credit to pave the way for others.”
Other co -authors affiliated with UTD included Joseph Epperson Bs’20, PHD’24, Txbdc Research Associate; Cognition and neuroscience Doctoral Student Emmanuel Adehunoluwa MS’23; Amy Porter MBA’20, Director of Operations of TXBDC; Holle Carey Gallaway MBA’23, Biomedical Research Engineer TXBDC; and David Pruitt ms’14, phd’16.
Kilgard has a financial interest in Microtransponder Inc., which markets pod stimulation therapy for stroke. Rennaker is the founder and CEO of Xnerve, who developed the device used in this study.
The investigation was financed by a subsidy (N66001-17-2-4011) of the Agency for Advanced Defense Research Projects, an agency of the Department of Defense, as well as the Alas Alas for Life Translation Program.
