Arlet Lara closes her fist and attempts to reopen it with assistance from occupational therapist Neil Batungbakal during her physical therapy appointment Sept. 9 at Jackson Memorial Hospital in Miami. Lara experienced a stroke in 2020 and has since had a device implanted in her chest to help her regain mobility in her arms.
MICHELLE MARCHANTE
Miami Herald
As her students finished their online exam, Arlet Lara got up to make a cafe con leche. Her 16-year-old son found her on the kitchen floor. First, he called Dad in a panic. Then 911.
"I had a stroke, and my life made a 180-degree turn," Lara said, recalling the medical scare she experienced in May 2020 in the early months of the COVID-19 pandemic. "The stroke aff ected my left side of the body."
Lara, an avid runner and gym-goer couldn't even walk.
"It was hard," said the 50-year-old mom from North Miami and former high school math teacher.
After years of rehabilitation therapy and a foot surgery, Lara can walk again. But she still struggles with moving.
This summer, she became the first patient in South Florida to get an implant of a new and only FDA-approved-nerve stimulation device designed to help ischemic stroke survivors regain movement in their arms and hands.
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Every year, thousands in the United States have a stroke, with one occurring every 40 seconds, according to the U.S. Centers for Disease Control and Prevention. The majority of strokes are ischemic, often caused by blood clots that obstruct blood fl ow to the brain.
For survivors, most of whom are left with some level of disability, the Vivistim Paired VNS System -- the device implanted in Lara's chest -- could be a game changer in recovery, said Dr. Robert Starke, a neurosurgeon and interventional neuroradiologist.
He also serves as co-director of endovascular neurosurgery at Jackson Memorial Hospital, where Lara underwent the procedure.
How the device works
The Vivistim Paired VNS System is a small pacemaker-like device implanted in the upper chest and neck area. Patients can go home the same day.
The U.S. Food and Drug Administration approved the stroke rehabilitation system in 2021 to be used alongside post-ischemic stroke rehabilitation therapy to treat moderate to severe mobility issues in hands and arms.
Lara's occupational therapist can activate the device during rehabilitation sessions to electrically stimulate the vagus nerve, which runs from the brain down to the abdomen and regulates various parts of the body's nervous system. The electrical stimulation rewires the brain to improve a stroke survivor's ability to move their arms and hands. Lara also has a magnet she can use to activate the device when she wants to practice at home. Her therapy consists of repetitive tasks, including coloring, pinching cubes and grabbing and releasing cylindrical shapes.
After several weeks of rehabilitation therapy with the device, Lara has seen improvement.
"Little by little, I'm noticing that my hand is getting stronger," Lara said in September. "I am already able to brush my teeth with the left hand."
Since then, Lara has finished the initial six-week Vivistim therapy program and is continuing to use the device in her rehabilitation therapy. She continues to improve and can now eat better with her left hand and can brush her hair with less difficulty, according to her occupational therapist, Neil Batungbakal.
Going beyond the 'plateau'
Starke sees the device as an opportunity to help bring survivors one step closer to regaining full mobility. Strokes are a leading cause of disability worldwide.
While most stroke survivors usually can recover some function through treatment and rehabilitation, they tend to hit a "major plateau" after the first six months of recovery, he said. Vivistim, when paired with rehabilitation therapy, could change that.
Jackson Health said results of a clinical trial published in the peer-reviewed medical journal The Lancet in 2021 showed that the device, "when paired with high-repetition, task-specific occupational or physical therapy, helps generate two to three times more hand and arm function for stroke survivors than rehabilitation therapy alone."
The device has even shown to benefit patients 20 years after their original stroke, according to Starke.
"So now a lot of these patients that had strokes 10 to 15 years ago that thought that they would never be able to use their arm in any sort of real functional way are now able to have a real meaningful function, which is pretty tremendous," Starke said.
More about the device
Vivistim's vagus-nerve stimulation technology was developed by researchers at the University of Texas at Dallas' Texas Biomedical Device Center and is being sold commercially by Austin-based MicroTransponder, a company started by university graduates. Similar devices are used to treat epilepsy and depression.
For Lara, the device is a new tool to help her recovery journey.
"Everything becomes a challenge, so we are working with small things every day because I want to get back as many functions as possible," Lara said.
Patients interested in Vivistim should speak with their doctor to check their eligibility. The FDA said patients should make sure to discuss any prior medical history.
"Adverse events included but were not limited to dysphonia (difficulty speaking), bruising, falling, general hoarseness, general pain, hoarseness after surgery, low mood, muscle pain, fracture, headache, rash, dizziness, throat irritation, urinary tract infection and fatigue," the FDA said.
MicroTransponder says the device is "covered by Medicare, Medicaid and private insurance with prior authorization on a case-by-case basis."
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