Vivistim Paired VNS System transforms future of stroke recovery

While great strides have been made in stroke prevention and acute stroke treatment over the past three decades, advancements in stroke recovery have lagged. Without effective treatment options for long-term stroke recovery, the focus has been on preventing long-term complications. In October 2022, Penn State Health became one of the first health care facilities in the country and the first in Pennsylvania to utilize the Vivistim Paired VNS System, a new neuromodulation device paired with specialized rehabilitation services that have the potential to transform the field of stroke recovery.

“Until very recently, a lot of trials were done, but there was very little that was promising regarding stroke recovery,” said Dr. Raymond Reichwein, stroke division chief, medical director of the Penn State Health Stroke Rehabilitation program, co-medical director of the Penn State Health Comprehensive Stroke Center and professor of neurology at Penn State College of Medicine. “We now have an FDA-approved device, the Vivistim System, that I think is going to take neurological/stroke recovery to the next level.”

Novel neuromodulation device and treatment

The Vivistim System gained approval and was designated as a Breakthrough Device by the FDA in August 2021.^1-2 The system, developed specifically to treat upper extremity motor function in adult ischemic stroke survivors, evolved from earlier implanted neuromodulation devices used in the treatment of medication-refractory epilepsy and depression.^3-4

The system involves implanting a two-part device for vagus nerve stimulation (VNS) that is then paired with an intensive rehabilitation protocol.^3-4 Signaling the VNS device leads to the release of neuromodulators that aid in creating new neural pathways when combined with prescribed upper extremity motor tasks. In the initial study, published in the Lancet, patients who used the device along with a specific rehab protocol demonstrated an increase in arm and hand function that was two to three times greater than those who received only rehabilitation.^3-4

Identifying ideal candidates

In addition to being ischemic stroke survivors and good surgical candidates, patients must meet certain criteria to receive treatment with the Vivistim System.⁵

The ideal candidate:

• Is at least six months post-stroke and no more than 10 years post-stroke
• Presents with moderate to severe upper extremity impairment
• Has previously received ongoing rehabilitation services and plateaued
• Maintains some active arm motor function, including in the wrist, thumb and at least two fingers, as assessed by the Fugl-Meyer Assessment for Upper Extremity
• Demonstrates adequate expressive and receptive communication skills
• Has the ability to follow two-step commands

During the assessment process, the Fugl-Meyer Assessment for Upper Extremity and the Wolf Motor Function Test are used to measure the patient’s active arm, hand and wrist movement to determine if they are likely to benefit from the Vivistim System.^4-5 However, a good fit on clinical measures is not the only criteria that counts when determining which patients are a match for the novel treatment.

“The importance of motivation cannot be overstated. It’s not just the stimulator alone that’s of value. It’s the coupling of the stimulation with intensive therapy,” Reichwein said. “You need a motivated, passionate patient. If we just place the device and turn it on, and the patient doesn’t do much therapy, it’s not going to work. The key is having the two together.”

Patients chosen to receive VNS treatment begin working with a team of providers that includes a neurosurgeon to place the device, a neurologist or physical medicine and rehabilitation provider who will follow them throughout their treatment, and a rehabilitation team of occupational therapists or physical therapists trained in the specific rehabilitation protocol.

Device placement

The Vivistim device is implanted under the skin in the upper chest to the left of the vagus nerve, and a stimulation lead is placed around the vagus nerve.⁴ The procedure takes approximately an hour and 15 minutes.

“The surgical procedure used to place the Vivistim has been around for decades. Even though the treatment for chronic stroke recovery is new, vagus nerve stimulation is not new. It’s not experimental,” said Dr. Michael Sather, surgical director of the Comprehensive Epilepsy Center at Penn State Health Milton S. Hershey Medical Center and professor of neurosurgery at Penn State College of Medicine. “For patients, it helps to hear that this isn’t some new procedure that’s never been done before. We know that it’s safe.”

Following the procedure, patients follow up with the neurosurgeon to ensure the surgical wound is healing well. Typically, they begin intensive upper extremity rehabilitation about one to two weeks after the procedure.

Intensive rehabilitation paired with vagus nerve stimulation

The Vivistim rehabilitation protocol calls for 18 sessions spread over six weeks. Each week, a patient has three 90-minute sessions focusing on the affected arm, hand and wrist.

During each session, the therapist uses a wireless transmitter to activate the Vivistim device while the patient participates in goal-oriented upper extremity motor tasks. Each session includes performing every task 30 to 50 times, for a total of about 300 purposeful movements per session.^3-4

The tasks fall into six categories that each relate to functional skills⁴:

• Gross movement
• Inserting objects
• Object flipping
• Opening and closing containers
• Reach and grasp
• Stimulated eating tasks

Once patients graduate from the intensive program, they transition to a self-directed, home-based therapy program. At this stage, the patient uses a magnet to activate the VNS daily for approximately 30 minutes while they perform exercises and functional tasks, such as folding laundry.

Improving function for life-changing results

Treatment with the Vivistim Paired VNS System has been shown to significantly improve motor function and strength.⁴ However, for patients and the team at Penn State Health, these achievements are only part of the success of the treatment.

“There’s a strong correlation between upper extremity impairment and poor quality of life,” Reichwein said. “This recent study had specific quality of life measurements. Patients reported that they not only saw improvement in motor function but also experienced a meaningful quality of life change. That’s the most important thing to me. People felt that their quality of life was much better with this treatment compared to without it.”

Tracking progress and looking toward the future

Three patients are scheduled to receive treatment with the Vivistim System at Penn State Health before the end of 2022. Sather reports that all three have agreed to be included in a national registry that will track their progress and collect additional information related to treatment outcomes. The registry will be a collaboration between the maker of the Vivistim, MicroTransponder Inc., and health care systems using the device. The data collected will be a part of a registered clinical trial that will follow patients for up to three years.⁶

“It often takes the discovery of a major breakthrough treatment to create the passion and excitement needed to expand resources. And I think we’re there. I think this device is the start of many more stroke recovery options,” Reichwein said. “In my experience, at least a quarter to a third of ischemic stroke survivors have significant upper arm/hand deficits, and many become chronic limitations regarding daily functioning. If we can help a reasonable number of those people, we will change the world for the better.”

Sather is hopeful the device might be studied to help treat other problems associated with stroke, such as leg and speech impairments.

“What’s very interesting about the vagus nerve is that it’s a relatively large nerve with broad connections throughout the brain, and therefore has the potential to be used for treating various diseases,” he said. “It’s great to have another disease entity and patient population that we can treat successfully with vagus nerve stimulation.”

References

1. Breakthrough Devices Program. FDA.gov. Reviewed August 3, 2022. Accessed October 4, 2022. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.
2. FDA Approves First-of-Its-Kind Stroke Rehabilitation System. FDA.gov. Published August 27, 2021. Accessed October 4, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-stroke-rehabilitation-system.
3. Fact Sheet. MicroTransponder.Showpad.com. Accessed October 4, 2022. https://microtransponder.showpad.com/share/fAYt5fhhEF9nnNb5VWZvZ.
4. Dawson, J, Liu CY, Francisco GE, et al. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021;397:1545–53. doi:10.1016/S0140-6736(21)00475-X. Accessed October 4, 2022.
5. Dawson, J, Liu CY, Francisco GE, et al. Supplementary appendix to: Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Accessed October 4, 2022.
6. Vivistim Registry for Paired VNS Therapy (GRASP) (GRASP). ClinicalTrials.gov. Posted March 29, 2022. Accessed October 4, 2022. https://clinicaltrials.gov/ct2/show/NCT05301140.