The Galician Office for Health Technology Assessment (Avalia-t) released a report with results of a review of the implantable device for upper-limb rehabilitation after stroke (Vivistim®). The report includes a review of evidence efficacy, but there is no cost-effectiveness revision due to the early development stage of the technology (clinical trial - phase III).
The Vivistim® system is a device that is implanted in the neck, and that stimulates the vagus nerve using specific software through a computer. This device enhances classic rehabilitation, and it also helps patients recover the movement of the upper-limb affected after a cerebrovascular accident.
The results of the review of clinical evidence include just a single randomized controlled trial. This study shows a few adverse events from which one was severe and also indicates an improvement in the intervention group compared to the group control regarding clinical efficacy. Based on these results, the report argues that the implementation of this device was safe and it's viable to use in adults with the weakness of the upper-limb. However, it was stated that considering the evidence (the study is done with a sample of 21 individuals), the study has low or moderate quality. The report suggests waiting until the finalization of the next clinical trial, which uses a more significant sample, to assess the validity of the previous results.
The document was created by the agreement of the Department of Health of the Autonomous Region of Galicia, together with the National Health Institute Carlos III and the Ministry of Economy.
See the full report in Spanish here.
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