According to the preliminary results of a randomized clinical trial at the 2021 annual meeting, vagus nerve stimulation (VNS) combined with intensive rehabilitation for months or even years after stroke can lead to better improvement in arm function than rehabilitation alone. the American Academy of Neurology.
“We believe that nerve stimulation combined with rehabilitation is an acceptable and effective intervention to improve the deterioration and function of the upper extremities in people with moderate to severe weakness of the arm for a long time. Fundamental study of VNS-REHAB is a randomized, blinded, controlled trial of 108 people who had weakness in the upper extremities after having a stroke at least 9 months prior to enrollment. The group mean was 3 years after stroke afterwards ischemic stroke, “he said Jesse Dawson, MD, Professor at the University of Glasgow.
Fifty-three patients were assigned active VNS followed by 6 weeks of rehabilitation at the clinic and after 90 days of rehabilitation at home. In rehabilitation at the clinic, the therapist initiated a 5-second burst of VNS stimulation during each movement. In the home treatment, the device was activated by a magnet.
Fifty-five patients were assigned simulated VNS. After 90 days, the fake group went on to receive VNS for 6 weeks and then 90 days of exercise at home. This cross-sectional group was the focus of the data that Dawson presented at AAN 2021. The overall results of the trial have been published to the Lancet.
“The hypothesis is based on the knowledge that VNS stimulates the release of proneuroplastic neuromodulators norepinephrine i acetylcholine“Said Dawson.” By pairing the VNS with task-specific movement, we hypothesize that we will increase task-specific neuroplasticity. “
The main study showed “a statistically significant difference between all primary and secondary endpoints at all times in favor of VNS-paired rehabilitation,” Dawson said. The main outcome was the improvement in the Fugl-Meyer Extremity Upper (FMA-EU) outcome, with an active VNS group with a significantly higher percentage of respondents. For example, 47% of active patients with VNS had a response greater than 6 points in the improvement of FMA-EU compared to 27% of the simulated group (Pg = 0.010).
When the simulated group switched to active VNS, the improvement in arm function coincided with that of the main study treatment group, Dawson said. “If you look specifically at what happened after completing the control phase, there was a small further increase in the Fugl-Meyer score, however, more importantly, between 20% and 35% achieved a clinically important response in the Fugl-Meyer Assessment or Test of Wolf Motor Function, which gives a number of treatments ranging from three to five, ”he said.
Dawson said data on adverse events were presented in the Lancet publication. “They were observed at the expected frequencies,” he said.
In an interview, he explained the importance of reporting the number to be addressed. “The number needed to treat helps give an idea of how many times you have to do something to achieve the desired result. Therefore, for VNS combined with rehabilitation versus rehabilitation alone, you need to treat four people to get a clinically important response, compared to with just doing therapy “.
The next steps for his group’s research, he said, “will be to try to explore whether we can predict who responds best and we would like to see if people with other types of stroke benefit.”
When commenting on the study, Andreas Luft, MD, a professor at the University Hospital of Zurich, noted that the reported FME-EU score improvements “are significant and significant … However, they can also be achieved by increasing the intensity of training. Many medical systems offer to his patients high-intensity rehabilitation and achieve similar improvements. It is likely that VNS may further increase higher-intensity training “beyond its limits,” but it remains to be demonstrated. “
Luft noted that the study advances the knowledge of combining a therapeutic approach with training. “More such approaches are needed to increase the therapeutic instrumentation of neurorehabilitation,” he said.
Dawson reported a financial relationship with MicroTransponder. Its co-authors reported relationships with MicroTransponder, SanBio, Fujifilm Toyoma Chemical, Medtronic, TRCare, SAEBO, Allergan / AbbVie, Ipsen, Merz, Ottobock / Hangar Orthopedics, Parker Hannifin, Revance Therapeutics, ReWallk and Sword Health. Three co-authors are employees of MicroTransponder. Luft has no relevant relationships to reveal.
This story originally appeared on MDedge.com, which is part of the Medscape professional network.