The AdventHealth Neuroscience Institute (NSI) recently became the first in the nation to complete and exceed 10 successful implantations of the Vivistim® Paired Vagus Nerve Stimulation (Paired VNS®) device, a first-of-its-kind, drug-free rehabilitation system recently approved by the U.S. Food and Drug Administration (FDA) to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke.
Up to 60% of ischemic stroke survivors have persistent upper limb impairment 6 months after their stroke. The hand and arm impairments can actually worsen over time and are associated with decreased quality of life as well as increased anxiety and depression.”
“Patients’ ability to regain function often plateaus,” explains AdventHealth NSI Medical Director and Neurosurgeon Ravi H. Gandhi, MD. “Up until now, effective long-term stroke recovery treatments have been limited.”
In a randomized, triple-blind, controlled clinical trial of 108 patients at 19 clinical sites in the U.S. and the U.K., the Vivistim Paired VNS System helped patients achieve 2-3 times more hand and arm function compared to conventional rehabilitation therapy alone.
A New Approach to Ischemic Stroke Rehabilitation
To use the Vivistim system, an implantable pulse generator (IPG) is placed just under the skin of the patient’s chest during an outpatient procedure. It can be performed as early as 4-6 months post stroke but can also be completed years after the stroke. Additionally, a lead wire that is attached to the IPG is implanted under the skin and leads up to electrodes that are placed on the left side of the patient’s neck where the vagus nerve is located.
One to 2 weeks after the device is placed, the patient can begin in-clinic occupational therapy at AdventHealth Sports Med and Rehab for 90 minutes, 3 times a week, for 6 weeks. The therapist uses a wireless transmitter that communicates with proprietary software to signal the Vivistim device to deliver a gentle pulse to the vagus nerve while the patient performs a specific task.
“This simultaneous pairing of the rehabilitation exercise with vagus nerve stimulation prompts the release of neuromodulators, including acetylcholine, norepinephrine and serotonin, helping to create or strengthen neural connections that improve upper limb function,” says Chandan Reddy, MD, AdventHealth NSI neurosurgeon and Director of Functional Neurosurgery at AdventHealth Celebration.
In addition to the in-clinic occupational therapy, each Vivistim patient is provided an individualized home exercise program. They are also provided with a magnet that can be passed over the VNS implant site to activate it, allowing the patient to complete 30-minute stimulation sessions during rehabilitative exercise or while performing functional tasks.
Improving Long-term Functional Outcomes
In the clinical trial to evaluate the safety and effectiveness of the Vivistim System, patients were split into a study group of 53 patients and a control group of 55 patients. Both groups were asked to complete 300-400 repetitions of functional tasks with the affected upper extremity 90 minutes a day, 3 times a week, for 6 weeks. Effectiveness was measured using the Upper Extremity Fugl-Meyer Assessment (FMA-UE). Patients in the treatment group achieved an average score increase of 5 points compared to 2.4 points in the control group. At 90 days post-therapy, 47.2% of those in the treatment group saw an improvement of 6 or more points in their FMA-UE score compared with 23.6% in the control group.
AdventHealth NSI has had 8 patients complete the initial 6-week protocol, and so far, these patients have achieved an average 10.4-point gain on the FMA-UE, 5.4 points higher than in the original clinical trial.
“We believe these superior outcomes speak to the quality of the individualized, evidence-based occupational therapy care provided by the AdventHealth team as well as the number of quality magnet swipes performed by VNS patients at home,” comments Dr. Reddy.
In the original study, patients did not start swiping their magnet at home until after 6 weeks of in-clinic rehab whereas AdventHealth patients can begin immediately upon starting their occupational therapy program.
“We’re excited to offer this breakthrough approach to ischemic stroke recovery that is helping many patients achieve a better quality of life,” shares Dr. Gandhi.