Spinal Cord Injury: Clinical Trial Results
Spinal Cord Injury Therapy Shows Promise in UT Dallas Study
Updated June 17, 2025
Dallas — Researchers at the University of Texas at Dallas’ Texas Biomedical Device Center (TxBDC) are reporting unprecedented recovery rates for individuals with spinal cord injuries. A study published May 21 in Nature details how closed-loop vagus nerve stimulation (CLV), combined with tailored rehabilitation, led too meaningful gains in arm and hand function.
The results pave the way for a pivotal trial, the final step before potential FDA approval of vagus nerve stimulation for upper-limb impairment related to spinal cord injury. The therapy, the result of over a decade of work, involves delivering electrical pulses to the brain via a small implanted device during rehabilitative exercises. Prior research demonstrated that vagus nerve stimulation during physical therapy can help rewire brain areas damaged by stroke.
Dr.michael Kilgard, neuroscience professor at UT dallas, noted the difference between this study and previous stroke-related research. “In stroke, people who do only therapy may get better, and adding CLV multiplies that improvement,” Kilgard said. “this study is different: Therapy alone for spinal cord injury didn’t help our participants at all.”
The trial included 19 participants with chronic, incomplete cervical spinal cord injuries. Each underwent 12 weeks of therapy, using video games to stimulate specific upper-limb movements. The implanted device activated upon successful movements, leading to improved arm and hand strength.
Dr. Robert Rennaker,professor of neuroscience and designer of the CLV device,said the activities help patients regain strength,speed,range of motion,and hand function,simplifying daily living.The study, which served as both Phase 1 and Phase 2 clinical trials, included a placebo-controlled phase. Nine participants received sham stimulation for the first 18 sessions before switching to active CLV.
Participants ranged from 21 to 65 years old, with injuries sustained one to 45 years prior. According to Dr. Jane Wigginton, chief medical officer at TxBDC, neither age, time since injury, nor initial impairment severity affected treatment response. “This approach produces results irrespective of these factors, which often cause significant differences in success rates of other types of treatment,” Wigginton said.
TxBDC has studied CLV for 13 years, leading to FDA approval of vagus nerve stimulation for stroke patients with impaired upper-limb movement.
“The people in this study have now gained the ability to do things that are meaningful for them and impactful in their lives,” Wigginton said.
The latest CLV device, designed by Rennaker, is significantly smaller and compatible with MRI, CT scans, and ultrasounds. A phase 3 trial involving 70 participants at multiple U.S. spinal cord injury centers is planned.
Dr. Seth Hays, bioengineering professor, emphasized the novelty of the research. ”Prior to this study, no person with spinal cord injury had ever received CLV,” Hays said. “This is the first evidence that gains can be made. Now we will set about determining how we make this optimally effective.”
hays cautioned that the therapy’s path to patients isn’t guaranteed, citing financial, regulatory, and scientific hurdles. The research team acknowledged the contributions of patients and partners at Baylor University Medical Center, Baylor scott & White Research Institute, and Baylor Scott & White Institute for Rehabilitation.
“These patients said, ‘Put that device in me’ — that’s a huge commitment. They deserve credit for paving the path for others,” Rennaker said.
What’s next
The team will focus on optimizing the effectiveness of CLV therapy as they prepare for the Phase 3 trial,bringing them closer to a potential new role in treating spinal cord injuries.