Deans' stroke musings: Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Saturday, June 22, 2019

Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke

Just who the fuck is incompetent enough to not know of all the previous vagus nerve research that they approved this new one? Names please, we need to embarrass the hell out of these people and get them out of the stroke world.
It is so easy, here are 40 posts on vagus nerve. If I, a stroke addled survivor can pull them up in 10 seconds, your stroke leaders should be able to do it in one quarter that time. Isn't it the responsibility of researchers to be up to date in their field of study? Especially their mentors and senior researchers? And still nothing that resembles a protocol for use of this.

The Fugl-Meyer upper extremity scale has no objective distinction for changes in ability and thus would be useless as a measurement tool.

Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke

Teresa J Kimberley1, Cec ılia N Prudente2, Navzer D Engineer2, David Pierce2, Brent Tarver2,Steven C Cramer3, David Alexander Dickie4and Jesse Dawson4

Abstract

Background:
Vagus nerve stimulation (VNS) paired with a motor task improves motor outcome in rat stroke models.It is hypothesised that VNS delivered during rehabilitation will improve upper limb function compared to controlrehabilitation therapy. Two pilot clinical studies demonstrated acceptable safety and feasibility of VNS paired withrehabilitation for improved upper limb function after stroke. Participants who received rehabilitation paired withVNS demonstrated clinically meaningful improvements in motor function that exceed gains seen among controlswho received similar rehabilitation without VNS. These preliminary data support a larger pivotal trial.
Methods:
VNS-REHAB (VNS-Rehabilitation) is a pivotal, multi-site, double-blinded, randomised trial designed to evaluate safety and efficacy of VNS paired with upper limb rehabilitation after ischaemic stroke. The study will include up to120 participants with upper limb weakness due to stroke nine months to 10 years prior. All participants will be implanted with a VNS device and randomised to receive either Active (0.8 mA) or Control VNS (0.0 mA) paired with upper limb rehabilitation. All participants receive 18 sessions of in-clinic therapy for six weeks, followed by a home-based therapy for three months. The rehabilitation therapy involves progressive, functionally based and intensive prac-tice of hand and arm tasks. VNS is delivered during each movement repetition. After blinded follow-up is completed, theActive vagus nerve stimulation group continues with home-based Active VNS and the Control group receive six weeks of in-clinic therapy with Active VNS followed by home-based Active VNS. The primary efficacy endpoint will be the difference in Fugl-Meyer assessment-upper extremity scores between the Active VNS and Control VNS groups at the end of six weeks of in-clinic therapy. Additional secondary endpoints will also be measured. Safety will be assessed with analysis of adverse events and device complications during study participation.
Discussion:
This pivotal trial will determine whether VNS paired with rehabilitation is a safe and effective treatment for improving arm function after stroke.Trial Registration:ClinicalTrials.gov, NCT03131960. Registered on 27 April 2017.