Combining brain stimulation with intense physical rehabilitation helped stroke survivors recover movement in their arms and hands and maintain these improvements for one year, according to a study presented at the American Stroke Association’s International Stroke Conference 2024.
Teresa J. Kimberley, a professor of rehabilitation science and physical therapy at MGH Institute of Health Professions in Boston, is the study’s lead author.
“The recovery of arm and hand function after a stroke often stalls or even declines, leaving many patients with chronic motor deficits that limit their independence and quality of life. New treatments that can boost the benefits of physical rehabilitation are desperately needed,” said Kimberley.
Vagus nerve stimulation is the first approved neuromodulation device to aid in chronic stroke recovery. It was approved by the U.S. Food and Drug Administration in 2021 to treat moderate to severe upper extremity motor function deficits (physical movement and coordination of arms and hands) associated with chronic stroke.
“This is the first time that brain stimulation combined with rehabilitation therapy for stroke is available outside of a clinical trial. It could set the stage for even more advancements in recovery from other impairments beyond the arm,” Kimberley said. “This is a watershed moment for rehabilitation science.”
This study represents one-year outcomes in the VNS-REHAB pivotal trial, which studied people who had a stroke resulting in moderate to severe upper extremity impairment.
Two groups of participants (108 total people) — a control group and an experimental group — completed six weeks of in-clinic, intense rehabilitation paired with active or sham vagus nerve stimulation. All participants were implanted with the nerve stimulation device and then randomized to receive either real nerve stimulation or a sham stimulation that only turned on for a few pulses. The in-clinic therapy was followed by a three-month home exercise program for both groups. The active vagus nerve stimulation group continued the home exercise program for a year. After the six-week period of sham stimulation, the control group crossed over and received six weeks of active vagus nerve stimulation followed by a year of the home exercise program.
Before and after the stimulation and rehabilitation therapies, motor function was assessed with the Fugl-Meyer Assessment-Upper Extremity, which assesses motor impairment, and the Wolf Motor Function Test, which is a time-based method to evaluate upper extremity motor ability while providing a better understanding of joint-specific and total limb movements.
The final study results represent outcomes for arm and hand function in 74 stroke survivors after one year of physical rehabilitation treatment. Data was unavailable for the remaining 34 participants mainly due to the COVID-19 pandemic.
This analysis found:
- At one-year, upper limb function improved by 5.3 points in the Fugl-Meyer Assessment-Upper Extremity and by 0.51 points in the Wolf Motor Function Test when compared to baseline.
- Vagus nerve stimulation therapy improved hand and arm function by 2-3 times more than intense rehabilitation alone.
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