Vivistim Paired VNS System Helps Restore Movement After Stroke

The Froedtert & MCW health network offers the Vivistim^® Paired VNS System.

Experiencing a stroke can significantly affect many aspects of life, especially arm and hand movement. For many stroke survivors, regaining the ability to use their upper limbs for daily tasks is a key part of rehabilitation. While traditional rehabilitation therapy is vital, new approaches are emerging to help patients achieve even greater progress. 

Vivistim is a technology designed to improve the recovery of arm and hand function for peopleliving with the effects of a stroke. It works with traditional rehabilitation to help the brain reorganize itself, which could lead to improved movement and more independence.

What Is Vivistim?

The Vivistim Paired VNS System is an FDA-approved medical device specifically developed for chronic ischemic stroke survivors who continue to experience ongoing upper limb impairment. It's a first-of-its-kind therapy that combines mild electrical pulses to a specific nerve with targeted physical therapy exercises.

"VNS" stands for vagus nerve stimulation. The vagus nerve is like a major highway of communication between the brain and many parts of the body. Vivistim uses gentle, precise stimulation of this nerve to create an environment in the brain that is more receptive to learning and strengthening new movements. This is a critical step in helping stroke patients regain control over their arm and hand.

How It Works

Vivistim involves two main parts working together: a small implanted device and focused rehabilitation therapy.

First, a tiny device is carefully implanted by a neurosurgeon under the skin in the chest area, similar to a pacemaker. A thin wire connects from this device to the vagus nerve in the neck. The device delivers very gentle electrical pulses.

The role for the device is rehabilitation itself. An occupational therapist plays a key role. During your therapy sessions, as you perform specific, repetitive movements with your arm and hand — like reaching for an object or practicing fine motor skills — the device delivers a brief, mild pulse to the vagus nerve. "Pairing" of nerve stimulation with physical movement is important.

Pairing helps the brain’s natural ability to adapt and rewire itself, a process known as neuroplasticity. Vagus nerve stimulation helps strengthen the brain's connections associated with specific movements you are practicing, making it easier for you to perform those actions over time. The therapy typically involves in-clinic sessions with your therapist, followed by exercises you continue to practice at home. This consistent approach over an extended time frame helps reinforce new neural pathways.

Who Can Benefit

Vivistim is specifically designed for chronic ischemic stroke survivors. This means individuals who experienced an ischemic stroke—the most common type of stroke, caused by a blood clot—and whose stroke occurred at least six months ago.

Ideal candidates for Vivistim therapy are those who continue to have moderate to severe upper limb impairment, affecting their arm and hand function, even after completing initial rehabilitation. It's also important for patients to be committed to participating actively in their prescribed rehabilitation therapy, as the device works in conjunction with these exercises.

A health care professional or an occupational therapist will conduct a thorough evaluation to determine if Vivistim is a suitable option for you based on your specific stroke history, current condition and rehabilitation goals.

What Are the Benefits

Studies, including the large VNS-REHAB trial, have shown that Vivistim Paired VNS Therapy can lead to significant improvements in upper limb function for stroke survivors. Patients often experience:

• Improved arm and hand function: This can translate to greater strength, control, and coordination in movements.
• Increased independence: As arm and hand function improves, patients may find it easier to perform daily activities such as eating, dressing, or writing, leading to a better quality of life.
• Long-lasting results: The therapy aims to create lasting changes in brain function, supporting long-term recovery.

The positive outcomes highlight Vivistim's potential as a valuable addition to stroke care, helping patients regain abilities they may have thought were lost.

Important Considerations

It's natural to have questions when considering a new therapy. Here are some common considerations:

Is Vivistim FDA-Approved?

Yes, is was approved by the FDA in 2021 for improving moderate to severe upper limb deficits in chronic ischemic stroke survivors. This approval was based on positive results from clinical trials demonstrating its safety and effectiveness.

Side Effects

Like any medical procedure or device, there may be side effects, although Vivistim is generally considered well-tolerated. Most side effects are mild and temporary, often related to the vagus nerve stimulation itself. Common side effects can include voice changes (like hoarseness), shortness of breath, throat pain, or coughing. These usually happen during stimulation and can often be managed by adjusting device settings. Your medical team will discuss all potential risks and benefits with you in detail.

Insurance Coverage

Insurance coverage can vary. As a newer, breakthrough technology, coverage policies are still evolving. It is highly recommended that you or your health care provider contact your insurance company directly to ask about coverage for the Vivistim Paired VNS System and related therapy. Your clinic's financial counselors may also be able to provide assistance and information regarding insurance verification.

The Vivistim Paired VNS System offers a promising new way for stroke survivors seeking to improve their arm and hand mobility. If you or a loved one are living with the effects of a stroke and want to improve upper limb recovery, discuss Vivistim with your doctor or rehabilitation specialist. They can help determine if this therapy is the right choice for your situation and rehabilitation.