Ohio State University Wexner Medical Center
Ken Meeks had a stroke following a serious car accident.
His left arm and leg haven’t been the same since.
The Ohio resident is hoping a device being studied in a new clinical trial will help return some function to his arm.
Meeks is taking part in the trial at the Neurological Institute at Ohio State University’s Wexner Medical Center. It’s one of the first hospitals in the world to try out an experimental treatment to help people recover from stroke.
Vivistim therapy involves the use of a neurotransmitter implanted just below the skin on the chest in a minimally invasive outpatient surgery.
The device is connected to the vagus nerve in the neck. The vagus nerve transmits signals to the brain, telling it what and when to learn.
The purpose of the device is to help “rewire” circuits in the brain that control motor functions.
Vagus nerve stimulation has been used to treat other conditions, including epilepsy and depression.
For this study, the device is being used along with rehabilitative therapy to see if the combination will help improve upper limb movement following a stroke.
According to the Centers for Disease Control and Prevention, almost 800,000 people in the United States have a stroke every year.
Stroke is one of the top causes of serious long-term disability.
Once the damage has been done, it takes a lot of work to make even small gains.
For people like Meeks, it’s worth trying something new.
Dr. Marcie Bockbrader is a research physiatrist for the Neurological Institute at Ohio State University’s Wexner Medical Center and a principal investigator for the trial.
She told Healthline that after a stroke, some of the brain’s connections that are important to movement get disconnected or destroyed. Many people have difficulty using their hands after a stroke.
The device may be promising, but it won’t be a quick fix.
Bockbrader notes that it doesn’t work on its own.
“It’s a device that helps the brain get into a state where it can benefit more from therapy. There’s a button that the therapist presses to activate the device as participants do therapy. The intent of the pulse is much like a heart pacer — to pace the brain. It’s about half a second of stimulation. We think that this very brief pulse is like a ‘wake up and pay attention’ to the brain to use what happens next to help relearn how to use a paralyzed limb,” she explained.
Bockbrader says this trial is focusing on the upper limbs in part because people need their hands to take care of themselves.
“If you can use your hands, you can do a lot of what you need to do with a wheelchair. If you can’t use your hands, you need people around to help more,” she said.
Bockbrader says some patients may feel a buzzing or tingling sensation from the stimulation. Others feel a hoarseness or lump in the throat when trying to swallow.
“There may be some discomfort from having the stimulation. If a patient doesn’t like that, we turn the intensity down. So, we’re still delivering pulses, but they can’t feel it,” she said.
The vagus nerve could potentially stimulate the muscles that help with swallowing. For that reason, the trial isn’t currently enrolling people who have difficulty swallowing.
“But it’s possible this therapy could eventually be used to help people who have trouble swallowing. That’s something that can be studied down the line after the device is shown to be safe and effective in this group of people,” Bockbrader added.
Meeks, 63, had his stroke in summer 2016.
He’d already been through a lot of therapy before joining the trial.
“When I left the hospital, my left arm and fingers were nearly completely paralyzed. By that, I mean it pretty much hung limp at my side. I had to move it with my right hand,” he told Healthline.
At first, much of his therapy involved just moving the hand and fingers in any way possible. As he progressed, he worked on trying to move small objects and using video games.
“Then my wife found this study on the internet, so I looked at it, signed up, and became patient number one at OSU,” he said.
He’s been hard at work for months now.
For the first six weeks, he had inpatient therapy for two hours a day, three days a week.
He’s currently in a one-month in-home rehabilitation phase. This involves a half hour of therapy every day.
Even home therapy isn’t easy, says Meeks.
“It’s hard enough to get up in the morning and go through this tedious process of getting dressed and getting a cup of coffee. Then to do therapy is difficult. More mentally than physically. You do repetitive things — gross motor movement, something for the fingers, then something for the wrist. Repetitiveness is the key to all of this,” he said.
Although he hasn’t felt any real change in his daily life, he’s hopeful and says he’s scoring better on tests.
“Neuroplasticity is a very slow process. The fact that I don’t see a change right now is, I don’t think, unexpected,” he said.
Meeks hasn’t had any side effects from the device aside from some discomfort right after the surgery.
Thirteen institutions in the United States, plus five in the United Kingdom, are taking part in this trial. And they’re still seeking participants.
“We’re looking at people in the chronic phase of stroke because it gives them the chance to recover naturally as much as possible,” Bockbrader said.
The typical participant is about nine months out from a stroke and has done all the therapies they’re eligible for.
“But we know the potential to improve is still there, though at a slower rate. This ability to improve lasts for years, so we’re accepting patients 10 years out from a stroke. It’s a fairly wide window,” she said.
To really be able to tell how much and whether the device is helping, the researchers are choosing a middle-of-the-road impaired population. This includes people who can flex and extend the wrist and move the thumb, but can’t use their hands the way they should for daily living.
“This suggests to us that connections between the arm and the brain are still there but not working at 100 percent efficiency. There’s still room for improvement. If the device is found to be effective, we can start looking at whether it can be beneficial for those more severely affected by stroke. It’s early on in the evaluation process,” Bockbrader said.
Recruitment will probably continue for the next two years.
Bockbrader says it’s a complicated three-phase study design. The initial two phases can last up to a year and a half.
“But if people choose to, we will keep the stimulator in and follow them yearly after that. There’s no end in sight for people who want to keep the stimulator in place and feel it’s helping. If they don’t, removal is a short outpatient surgery,” she said.
Interested stroke survivors can contact the recruitment office of the nearest participating institution.
“Because it’s fairly intense therapy in the clinic for the first six weeks, it’s helpful if they live nearby one of the study centers,” Bockbrader said.
If accepted, participants aren’t responsible for study-related expenses. The study is sponsored by MicroTransponder Inc., developer of the Vivistim device.
The trial is ongoing and double-blind, so Meeks doesn’t know yet if he’s in the control group or not.
But he doesn’t hesitate to recommend the study to others dealing with the aftermath of stroke.
“First of all, it will probably help you, even if only from the therapy itself. And from an altruistic point of view, anything that moves the science forward will not only help you in the long run, but will help somebody else,” he said.
And he has some other advice for stroke patients.
“Use anything you can find in your environment that helps you keep moving forward. If you keep moving, then you’ll keep making progress, even if it’s small, and you won’t backslide,” he said.
Bockbrader believes that regardless of where someone is in recovery after a stroke, there’s always potential to get better.
“There’s this idea that you’ve reached a maximum level of function after certain therapies or a certain amount of time. The reality is that’s probably not true. To get better, people often have to go off the beaten track to get an opportunity to boost their potential. That’s one of the things I like about studies like this. It’s one of the ways you can do that,” she said.