Kate Hayward, PhD PT
European Stroke Organisation-World Stroke Organization 2020 Virtual Conference
November 7-9, 2020
ESO-WSO 2020 Large Clinical Trials & Awards
Presenter: Professor Jesse Dawson
Presentation title: Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-Rehab): A randomised, blinded, pivotal, Phase III device trial
There is much work occurring to identify adjuvants that may boost post-stroke motor recovery — particularly upper limb recovery, which often remains an unmet need for many stroke survivors long-term. The current work focused on vagus nerve stimulation (VNS) as an adjunct to motor rehabilitation and built upon two prior pilot randomized controlled trials of this intervention.1,2 The pilot trials suggested potential for a functional benefit of VNS when combined with intensive motor rehabilitation. The mechanistic rationale put forward to underpin this intervention was that VNS activates release of neuromodulators, which may facilitate behavioral and physiological changes that support motor recovery.
In this randomised, blinded, Phase III trial,3 eligible participants had to have experienced a unilateral ischemic stroke 9 months to 10 years prior to enrolment and demonstrated a Fugl Meyer Assessment Upper Extremity (FMA-UE) score of 20 to 50 points (out of 66 points). This is consistent with moderate to moderately-severe impairment as all participants would be expected to demonstrate some movement if scoring within this range. All enrolled participants had a VNS device implanted and were randomized to receive an active or sham stimulation protocol. Of note, all participants received 5 active stimulations (varying intensities) at the commencement of each in-clinic session, which was designed to expose everyone to a very small volume of VNS and to maintain blinding. All participants received 6 weeks of in-clinic rehabilitation (3 session per week for 2 hours aiming for >300 repetitions) followed by 90 days of at home-rehabilitation (daily therapist prescribed home exercises). Follow up occurred at 1, 30, and 90 days post completion of in-clinic rehabilitation.