Brain implant for stroke: Cleveland restaurant icon among first to try new treatment

CLEVELAND, Ohio —Tommy Fello, owner of the iconic Tommy’s Restaurant in Cleveland Heights, hadn’t missed a day in the kitchen in 19 years — until he had a stroke on Christmas Day 2023.

Even after years of physical therapy, muscle stiffness and weakness in his left arm and leg made it impossible for him to get back to whipping up each day’s specials.

Then a fellow stroke patient told Fello about the first FDA-approved treatment for stroke. It was an implant that stimulates the brain, helping create new neurological pathways to improve muscle function.

This April, Fello became the first patient at the Cleveland Clinic to receive the Vivistim System. Developed by the Texas-based company MicroTransponder, it combines stimulation of a major nerve with intensive physical therapy to help patients regain function in their hands and arms, even several years after a stroke.

Now Fello, 73, is able to walk around his home in Novelty, make oatmeal and wash the bowl — all things that were previously impossible for him to do.

“These are really minuscule things, but they’re gigantic mountains when you have a stroke,” Fello said. “I’m starting to show progress, and I’m very happy that I did it.”

The Clinic, one of the first Ohio hospitals to offer the Vivistim device, has treated about eight patients as of mid-August, said Dr. Mark Bain, cerebrovascular neurosurgeon at the Clinic.

“This is very exciting for us and for more importantly, for patients, because they have an option now,” said Bain, who runs the Clinic’s Vivistim program and is Fello’s physician. “Once their recovery has plateaued and rehab is no longer working, we have something that we can offer patients to regain that function.”

Stroke symptoms improve with implant

An ischemic stroke, like the one that Fello suffered, happens when a blood clot stops blood from reaching a part of the brain.

Physicians can take measures to remove blood clots in the brain immediately following a stroke. But after the crisis has passed, the only treatment until recently was physical therapy to overcome physical disabilities and limb weakness, Bain said.

The Vivistim System offers a new way forward. It targets the vagus nerve, a major part of the nervous system controlling heart rate, digestion and other important functions.

Vagus nerve stimulation uses a device to send electrical impulses to the vagus nerve. Bain said. The device is implanted under the skin in the chest. A wire threaded under the skin connects the device to the left vagus nerve. To change brain activity, the device sends electrical signals along the nerve to the brainstem in the neck.

A physical therapist uses a wand to activate the stimulation device during rehabilitation therapy sessions. Patients can also turn it on while doing daily tasks at home. The stimulator typically stays on for about four hours.

“When I get home and I want to do stuff, I swipe this magnet over the device, and it triggers it to send impulses (to my arm muscles) every 30 seconds,” Fello said.

In a 2021 clinical study published in the Lancet, about half of the patients who received the implant and physical therapy showed improvement, as compared with only a quarter of patients in the control group. The study was funded by MicroTransponder.

“Almost every patient I operated on had some improvement — some dramatic and some minor, but even minor things have been great,” Bain said.

Fello is among about 700 patients across the United States who have received the vagus nerve stimulation implant.

The Vivistim System program was challenging to launch at the Clinic because it requires input from a surgical team, rehabilitation physicians, occupational therapists and other specialists.

“Before we can implant, we have to make sure that all the rehab is already set up, because there’s a very strict timeline that’s got to be coordinated,” Bain said.

Vagus nerve stimulation must be paired with six to eight weeks of intensive rehabilitation therapy that involves longer and more frequent sessions than conventional therapy, Bain said.

“If you just do one or the other, you don’t get the full benefit of the device,” he said.

Typically, health insurance only pays for 60-minute sessions for three months of rehabilitation therapy, Bain said. Patients with the implant need 90-minute sessions over six to eight weeks.

Immediately after his stroke, Fello was unable to walk and move his left arm. He also had pain when using his right arm to move his paralyzed arm.

Now his busy weekly routine includes sessions with occupational and physical therapists as well as stretching and dry needling, a therapy that helps relieve muscle pain.

Like Fello, other stroke patients are learning about the device by word-of-mouth, and contacting the Clinic to find out if they might be candidates for the implant, Bain said.

“We had a patient who heard about it on Instagram and gave us a call,” Bain said.

Stroke patients who are candidates for the vagus nerve device must have a certain amount of mobility in their arms. People with too much or too little mobility generally are not good candidates, Bain said. “There’s sort of the sweet spot right in the middle,” he said.

So far, researchers have only looked into vagus nerve stimulation to treat weakness in the arms, not the legs. Bain thinks the technique could benefit other regions of the body affected by stroke, as well as speech and language issues, but the possibilities have not yet been studied.

Bain and his patients are still learning the limits of what the device can do. Will the increased arm mobility plateau at a certain point? And if so, will it be safe to leave the implant inside the body?

“All these questions need to be answered,” he said.

Bain is encouraged when he sees how much Fello has improved.

Family members and staff have kept Tommy’s Restaurant going in his absence, and Fello stops in a few times a week to say hi to staff and customers. He misses not being there full time, but remains upbeat about the future.

“I’m hoping I (improve 100%), but you never can tell,” Fello said. “But there are so many other things I can do (at the restaurant). I could be the greeter. I definitely want to get back, but it might be in a different role.”