New Hope for Spinal Cord Injury Patients: Closed-Loop Vagus Nerve Stimulation Shows Promise
A groundbreaking clinical trial is offering a beacon of hope for individuals living with spinal cord injuries. Researchers have demonstrated that closed-loop vagus nerve stimulation (CLV) can lead to functional gains, even in patients years post-injury and with varying degrees of impairment. The study, a significant first as no prior research had explored CLV for this condition, involved a Phase 1 trial with 19 participants.
The initial phase incorporated a randomized, placebo-controlled design. nine participants received sham stimulation for the first 18 therapy sessions, followed by active CLV in the subsequent 18 sessions. Notably, the degree of betterment wasn’t linked to age (ranging from 21 to 65) or time as injury (from one to 45 years), or the severity of existing hand movement limitations – a departure from typical treatment outcomes.
“This approach produces results regardless of these factors, which often cause significant differences in success rates of other types of treatment,” explained Dr. Jane Wigginton, medical doctor, chief medical officer at TxBDC, co-director of UTD’s Clinical and Translational Research Center, and medical science research director at the Center for BrainHealth. Dr. Wigginton, who oversaw clinical interactions and patient safety protocols, emphasized the “remarkable” medical implications of the findings.
TxBDC has spent 13 years researching CLV, culminating in FDA approval of vagus nerve stimulation for upper-limb movement impairment in stroke patients. This latest research is particularly encouraging as it addresses a population with limited existing treatment options. “The people in this study have now gained the ability to do things that are meaningful for them and impactful in their lives,” Dr. Wigginton stated.
The CLV device itself has undergone significant advancements. The newest generation, designed by Dr. Robert Rennaker, is 50 times smaller than its predecessor and is compatible with MRI, CT, and ultrasound imaging.
looking ahead, a Phase 3 pivotal trial is planned, involving 70 participants across multiple U.S. institutions specializing in spinal cord injury. Dr. Seth Hays,associate professor of bioengineering,highlighted the study’s pioneering nature: “Prior to this study,no person with spinal cord injury had ever received CLV. This is the first evidence that gains can be made.” He added that the focus now shifts to optimizing the therapy’s effectiveness.
However, Dr. Hays cautioned that success isn’t guaranteed. “we still have a long road ahead.For many reasons - financial, regulatory or scientific – this could still die on the vine,” he acknowledged, while expressing optimism about their current position.
The research team underscored the collaborative effort of the numerous individuals involved, including the patients themselves and partners at Baylor University Medical Center, Baylor Scott & White Research Institute, and Baylor Scott & White Institute for Rehabilitation. dr. Wigginton praised the team’s dedication and altruism,while Dr.Rennaker commended the patients’ willingness to undergo surgery despite their mobility challenges, calling it a “huge commitment.”
The UTD-affiliated co-authors included Joseph Epperson, Emmanuel Adehunoluwa, Amy Porter, Holle Carey Gallaway, and David pruitt. Researchers disclosed financial interests: Dr.Kilgard has a stake in MicroTransponder Inc., and Dr. Rennaker is the founder and CEO of XNerve,the device developer.
The research was supported by a grant from the Defense Advanced Research Projects Agency (DARPA) (N66001-17-2-4011) and the Wings for Life Accelerated Translational Program.