Summary: An innovative clinical study shows that stimulation of the vagus closed circuit nerve (CLV), together with rehabilitation, can significantly improve the function of arms and hands in people with chronic spinal cord lesions. The therapy uses a small implemented device that sends electric pulses timed to the brain when patients perform successful movements, helping to recover neuronal circuits.
Participants who previously did not see any benefit of therapy experienced an unprecedented recovery through CLV, regardless of their age, duration of injury or severity. These results mark an important step towards the potential approval of the FDA and offer hope to patients without current treatment options.
Key facts:
Advance recovery: The CLV led to important functional profits in the upper limbs for patients with spinal cord injury. Technology: A small implant sends electric pulses during directed movement therapy.
Source: UT Dallas
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: alone therapy for spinal cord injury did not help our participants at all.”
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.
“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.
FINANCING: The investigation was financed by a subsidy (N66001-17-2-4011) of the Agency for Advanced Defense Research Projects (DARPA), an agency of the Defense Department, as well as the Wings For Life accelerated Translation Program.
About this research news from Neurotech and Sci
Author: Stephen Fontenot
Source: UT Dallas
Contact: Stephen Fontenot – UT Dallas
Image: The image is accredited to Neuroscience News
Original research: open access.
“The stimulation of the vago closed circuit nerve helps the recovery of the spinal cord injury” by Michael Kilgard et al. Nature
Abstract
Closed vague circuit nerve stimulation helps recovery of spinal cord injury
Decades of research have shown that the recovery of serious neurological lesions will require synergistic therapeutic approaches. Recovering the neuronal circuits after the lesion is a long -standing target of the neurorrehabilitation.
We presume that combining intensive, progressive and task training with the stimulation of the vago closed circuit nerve in real time (CLV) to improve synaptic plasticity could increase resistance, expand the range of movement and improve hand function in people with chronic and incomplete lesion of the cervical spinal cord.
Here we report the results of a prospective, double blind, simulated, randomized study that combines gamified physiotherapy using strength and movement sensors to administer simulated or active CLV (clinicaltrials.gov identifier NCT04288245).
After 12 weeks of therapy composed of a miniaturized implant that selectively activates the vagus nerve in successful movements, 19 people exhibited a significant beneficial effect on the strength of the arm and hand and the ability to perform activities of daily life.
CLV represents a promising avenue for people with chronic and incomplete injury of the cervical spinal cord.
