Trudy Coleman was enjoying an early October day in her backyard with her two pugs.
Then she collapsed.
The Kingston resident crawled inside to dial 911. That’s when she realized her speech was slurred.
Coleman had an ischemic stroke on Oct. 7, 2023. She spent more than a year working to get back to her pre-stroke capabilities.
She spent a week in the hospital, followed by inpatient therapy, then home therapy and finally outpatient therapy.
“I worked as hard as I could at it because I was determined,” Coleman said. “I'm not going to let this stop me. But I reached that plateau.”
Now, thanks to recently FDA-approved Vivistim implant technology, Coleman is back to doing some of her favorite activities, many of which she never thought she’d be able to do again.
“My biggest accomplishment before I had the implant was being able to drive,” she said.
Her occupational therapist at Allied's Wilkes-Barre rehab hospital, Lori Ackerman, said Coleman is almost back to 100% after receiving the implant in November of 2024. She, and Coleman, credit her progress to the technology they took a chance on.
“After the Vivistim, I was able to add the things I most like doing, like painting and drawing and crocheting,” Coleman said.
What is Vivistim?
Vivistim uses paired vagus nerve stimulation (VNS) to aid stroke recovery.
The U.S. Food and Drug Administration (FDA) approved the device for use in 2021.
Medicaid, Medicare and private insurance can cover the device placement surgery and following therapy, according to Matthew Bernardo, a therapy development specialist at MicroTransponder, Inc, the company that makes Vivistim.
Patients using Vivistim to aid recovery saw two to three times greater improvements in motor and impairment and function compared to patients doing just rehabilitation, according to data from the FDA.
“Clinical studies and real-world evidence demonstrate that Vivistim helps stroke survivors improve hand and arm function two to three times more than traditional stroke therapy alone, and that these gains are maintained for at least one year after completing the initial course of therapy,” Bernardo said. “Many Vivistim users report that this improved upper limb function enables them to better perform activities of daily living such as getting dressed, preparing and eating meals, and folding laundry.”
So far there are only about 70 stroke survivors using Vivistim in Pennsylvania, Bernardo said.
Allied’s Wilkes-Barre rehab hospital has two patients, including Coleman, who currently have the Vivistim implant, and Coleman is believed to be the first patient to undergo the implant surgery locally.
Stimulating the vagus nerve
The vagus nerve is part of the parasympathetic nervous system. It’s responsible for involuntary motor and sensory functions and carries signals between the brain, heart and digestive system.
Coleman’s stroke happened on the left side of her brain, meaning the right side of her body was affected.
The implant is in the left side of Coleman’s chest wall with a coil that wraps up to the vagus nerve in her neck.
Ackerman uses a small clicker that sends a signal to the device that travels through the coil. That stimulates Coleman’s vagus nerve as she performs tasks like stacking blocks, writing or coloring during therapy sessions.
“Every time I do that, I stimulate the vagus nerve in her neck,” Ackerman said. “By the time I'm done, I would love to have between 300 to 500 stimulation counts in the session. When Trudy is not with me, she has a magnet that she uses, which she swipes the transponder, and she does homework at home, so she sets it off for about 30 minutes.”
Who’s eligible for Vivistim?
Vivistim works for adult ischemic stroke survivors with upper limb impairment six months post-stroke.
The American Stroke Association says an ischemic stroke “occurs when a vessel supplying blood to the brain is obstructed. It accounts for about 87% of all strokes.”
Good candidates for the implant must be willing and able to complete intensive therapy, including “homework.”
Allied patients go to 18 in-clinic rehabilitation sessions three times a week that last an hour and a half immediately after recovery from the implant surgery.
Ackerman knew Coleman was a good candidate because she saw how committed Coleman was to regaining her independence.
“In order to get this device, you have to be committed to doing things at home,” Ackerman said. “If you're not going to do a home program ... then this device isn't for you.”
Coleman did not hesitate to give the new technology a try.
“It didn't take any time at all for my decision,” she said. “Anything that would get me back to normal was fine with me.”
Candidates also need to have some active movement of wrist and some fingers. Coleman was already driving before Vivistim.
Potential risks and side effects of implantation
Penn Medicine found the risks of VNS come mostly from the implantation surgery. Those risks include: infection, inflammation or pain at the incision site and vagus nerve damage that can cause hoarseness or difficulty swallowing.
“After Trudy had the implant, the only issue we observed with her was a little bit of coughing and a little bit of hoarseness in her voice, which resolved after she got used to the implantation,” Ackerman said.
Coleman also said she was in pain after the surgery. Patients are typically discharged the day of surgery.
“There were two days after that were very painful, and that was it,” she said. “The doctor had prescribed pain pills if I needed them, and I didn't think I would the first day. But then, when everything had completely worn off, it was very painful, and I had to take the pain pills, but then was fine.”
The implant’s battery life lasts about five years. Ackerman said it’s up to patients whether they want to remove the device or not. The coil never comes out because of the scar tissue that builds up around it.
Speeding up stroke recovery
Ackerman has been Coleman’s occupational therapist since late 2023. She’s very happy with the progress Coleman’s made since receiving the implant.
“From reaching a plateau, I think we said at about 75% in general rehab, once the transponder and the implant was put into her and she came back for rehab, she's about 95% of where she was before her stroke,” Ackerman said.
“By the end of the six weeks [of therapy post implant], I think we saw remarkable changes,” she continued.
She wants other stroke survivors to consider this option.
“It's exceeded my expectations at this point, just watching Trudy. Now for future patients that I may have or clients, I know what to look for,” Ackerman said.
Coleman said the device sped up her recovery.
“Probably I would be doing at least another year and a half [of rehab] without it,” she said. “I have eight more sessions of one hour a week, and then I'm free.”
She encourages other patients to take the leap.
“By all means, give it a shot. Give it a try, because the improvement, if you're willing to put the work in, is amazing,” Coleman said.
