Rehabilitation therapy researchers and clinicians embrace the FDA-approved, first-of-its-kind Vivistim® Paired VNS™ System with a positive outlook as an effective, outcomes-based adjunct intervention for survivors of ischemic stroke.
Manufactured by MicroTransponder® Inc., a medical device company developing solutions to restore independence and dignity for people suffering from neurological conditions that impair sensory and motor function, the Vivistim System pairs vagus nerve stimulation with rehabilitation therapy to improve upper limb function for stroke survivors.
Results of MicroTransponder’s 108-person, multicenter, triple-blinded, randomized controlled pivotal clinical trial, published in The Lancet, show that the Vivistim System generates two to three times more hand and arm function for stroke survivors than rehabilitation therapy alone.
These results, along with the assertion of a paradigm shift in stroke rehabilitation, were presented by Teresa Jacobson Kimberley, Ph.D., PT, FAPTA, a professor at MGH Institute of Health Professions, and Steven L. Wolf, Ph.D., PT, FAPTA, FAHA, FASNR, a professor in the Division of Physical Therapy at Emory University School of Medicine, during the American Physical Therapy Association’s 2022 Combined Sections Meeting. Kimberley and Wolf, who led the Vivistim clinical trial at their respective institutions, facilitated a symposium titled “Applying the Evidence: The Emerging Role of Vagus Nerve Stimulation Paired with Stroke Rehabilitation.”
As Paired VNS Therapy garners more recognition for being an innovative, results-oriented intervention in stroke recovery, Wolf advocates for buy-in from rehabilitation specialists by underscoring that this new intervention is a complement to therapy, not a replacement.
According to occupational and physical therapists who participated in the clinical trial, the Vivistim System enables therapists to guide stroke survivors to significant improvements in upper limb mobility because of the innovativeness of the technology, the therapy’s unique in-clinic protocol and the system’s capability to be activated at home by the patient.
During Vivistim Therapy, a therapist will use a wireless transmitter that communicates with proprietary software to signal the implanted Vivistim device to deliver a gentle pulse to the vagus nerve while the stroke survivor performs a specific task, such as putting on a hat, brushing hair or cutting food. Through Vivistim’s at-home feature, stroke survivors can continue practicing rehabilitation exercises or practice routine tasks on their own by swiping the Vivistim magnet over the implant area.
Researchers believe that the simultaneous pairing of the rehabilitation exercise with vagus nerve stimulation releases neuromodulators that create or strengthen neural connections to improve upper limb function and increase the benefit of physical therapy.
Therapists evaluate their patient’s upper limb function during each Vivistim Therapy session to tailor the exercises around hand and arm functions that need the most improvement. According to Yozbatiran, patients reported that they felt challenged during the sessions and appreciated the intensity.
Even though the Vivistim System protocols are extensive, most therapists in the clinical trial report that it’s easy to integrate into their practice. During the clinical trials, 71% of therapists said it was easy or very easy to trigger the vagus nerve stimulation during therapy.
Clinical teams are currently identifying potential candidates for the Vivistim System, with the first commercial implantation of Vivistim expected in the first half of 2022. Rehabilitation specialists, physiatrists, neurologists and neurosurgeons interested in learning more can click here and assess if their patients are ideal candidates for the Vivistim System.
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