New FDA-Approved Device for Stroke Rehabilitation Now Available for Patients at Jefferson Health

PHILADELPHIA –Stroke affects nearly 14 million people worldwide per year, and can frequently produce loss of mobility. Patients can regain some function with intensive rehabilitation therapy for the first few months after stroke, but this recovery often plateaus and patients are left with a ‘new normal.’ To combat this plateau, Jefferson Health surgeons recently became the 5th center in the United States to implant a new FDA-approved device that improves the effectiveness of rehabilitation therapy and helps restart recovery to improve a stroke survivor’s upper mobility.

“For some patients post-stroke, paired vagus nerve stimulation may offer a path to a better quality of life and greater independence,” says Robert Rosenwasser, MD, president of the Vickie and Jack Farber Institute for Neuroscience – Jefferson Health, and Osterholm Professor and Chair of the Department of Neurological Surgery at Thomas Jefferson University. “Jefferson is leading the charge in offering patients access to the best care and most effective medical technology at all stages of stroke care and recovery.”

The device, called Vivistim, is placed under the skin in the upper chest and stimulates the vagus nerve in the neck, which sends signals to the brain leading to additional release of neurotransmitters. Vagus nerve stimulation (VNS) is an extensively researched option for several neurological conditions and is also FDA approved to treat specific cases of depression and epilepsy. The results of a triple-blinded, randomized controlled clinical trial published in The Lancet, show that pairing VNS therapy with post-operative rehabilitation can generate two to three times more hand and arm function for stroke survivors than rehabilitation therapy alone. Mobility and control improved even in patients who were several years out from their stroke, at a time when little improved mobility is expected from additional rehabilitation.

The first Jefferson patient, who suffered a stroke two years ago, had surgery with Dr. Reid Gooch, Assistant Professor of Neurosurgery, in late October and recently began rehabilitation with a dedicated team of neurological occupational therapists at MossRehab.

 “Jefferson is exploring many avenues to help restore post-stroke patients’ daily function and abilities,” says neurologist Mijail Serruya, MD, PhD, co-director of the Center for Neurorestoration at the Farber Institute for Neuroscience. “Technologies that improve or augment the connection between brain and paralyzed parts of the body are promising. We seek to make innovative treatments – whether developed in industry, or here in our new Center, available to improve outcomes for patients.”

During rehabilitation therapy, the device is activated to give a gentle pulse to the vagus nerve while the patient performs a specific task, such as reaching for a cup, or cutting food. The stimulation helps strengthen the automatic learning pathways so that these actions become easier to perform. After in-clinic Paired VNS Therapy is initiated, Vivistim can be used by the patient at home as directed by their rehabilitation specialist.

“Rehabilitation therapy is an essential component of stroke recovery,” says Alberto Esquenazi, MD, CMO of MossRehab and now part of Jefferson Health. “Together, with our extremely hard-working patients, we can help reestablish the connections between brain and limb, ultimately helping patients improve function. Technologies that help patients gain improved function are incredibly valuable.”

“We applaud the teams at Jefferson Health and MossRehab for envisioning Vivistim System as part of the complete care that is offered by their comprehensive stroke center to improve stroke survivors’ independence and quality of life,” says Richard Foust, CEO of MicroTransponder, a medical device company that develops solutions to restore independence and dignity for people suffering from neurological conditions that impair sensory and motor function. “Paired VNS Therapy addresses an unmet need for those who have chronic impairment after a stroke, so it’s a significant milestone for survivors that Vivistim programs are being built here and across the country.”

Involved in this Initiative: Neurosurgery: Robert Rosenwasser, Reid Gooch, Pascal Jabbour, Stavrapoula Tjoumakaris, Chengyuan Wu, Nabeel Herial, Nancy Tworek; Neurology: Robin Dharia, Diana Tzeng, Elan Miller, Shaista Alam, Lisa Bowman, Rodney Bell; Rehabilitation: Steve Williams , Alberto Esquenazi, Davis Berzin,; Center for Neurorestoration: Mijail Serruya, Ashwini Sharan, Joe Kardine, Dana Johnson, Gabrielle Carpino , Erica Jones, Alessandro Napoli, Phyo Thuta Aung, Rachel Zarin, Nabila Shawki, Daniel Verbit, Michelle Mattera Keon.