Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke

Abstract

safety, feasibility, and efficacy of VNS paired with upper limb rehabilitation in chronic ischemic stroke, with blinded, sham VNS control. Methods This article adheres to the American Heart Association Journals' implementation of the Transparency and Openness Promotion Guidelines. Requests for data will be considered by the corresponding author after Food and Drug Administration postmarket approval. This was a randomized, sham stimulation controlled, and fully blinded study of VNS paired with rehabilitation in people with arm weakness after ischemic stroke. Participants in both groups were implanted with the VNS device. Participants, therapists, and outcome assessors were blinded to group allocation. The study was approved by an institutional review board at each institution and subject to appropriate regulatory approvals (Food and Drug Administration investigational device exemption No. 130287 and UK Medicines and Healthcare Products Regulatory Agency [MHRA] Background and Purpose-We assessed safety, feasibility, and potential effects of vagus nerve stimulation (VNS) paired with rehabilitation for improving arm function after chronic stroke. Methods-We performed a randomized, multisite, double-blinded, sham-controlled pilot study. All participants were implanted with a VNS device and received 6-week in-clinic rehabilitation followed by a home exercise program. Randomization was to active VNS (n=8) or control VNS (n=9) paired with rehabilitation. Outcomes were assessed at days 1, 30, and 90 post-completion of in-clinic therapy. Results-All participants completed the course of therapy. There were 3 serious adverse events related to surgery. Average FMA-UE scores increased 7.6 with active VNS and 5.3 points with control at day 1 post-in-clinic therapy (difference, 2.3 points; CI, −1.8 to 6.4; P=0.20). At day 90, mean scores increased 9.5 points from baseline with active VNS, and the control scores improved by 3.8 (difference, 5.7 points; CI, −1.4 to 11.5; P=0.055). The clinically meaningful response rate of FMA-UE at day 90 was 88% with active VNS and 33% with control VNS (P<0.05). Conclusions-VNS paired with rehabilitation was acceptably safe and feasible in participants with upper limb motor deficit after chronic ischemic stroke. A pivotal study of this therapy is justified.

Functional Vagotopy in the Cervical Vagus Nerve of the Domestic Pig: Implications for the Study of Vagus Nerve Stimulation

“…The Food and Drug Administration (FDA) approved vagus nerve stimulation (VNS) in 1997 as an adjunctive therapy in adults with partial onset epilepsy refractory to medications (Morris et al 2013) (FDA, 1997). Subsequently, VNS was FDA approved for the treatment of depression (Wheless, Gienapp, and Ryvlin 2018), and is in clinical trials for diverse conditions such as hypertension (Ng et al 2016), heart failure (De Ferrari et al 2017), rheumatoid arthritis (Koopman et al 2016), tinnitus (Tyler et al 2017) and stroke rehabilitation (Kimberley et al 2018). Despite the growing clinical interest and some remarkable success in individual patients, VNS therapeutic effects are variable from patient to patient and are often limited by side effects including cough, throat pain, voice alteration and dyspnea (De Ferrari et al 2017).…”

An implant for long-term cervical vagus nerve stimulation in mice

“…In addition to its approved use in treatment-resistant epilepsy [1] and depression [2], vagus nerve stimulation (VNS) may provide new treatment options for a wide range of illnesses. Long-term VNS is currently being explored in the treatment of brain disorders, such as tinnitus [3,4], stroke [5,6], and Alzheimer's disease [7,8], as well as peripheral organ and systemic diseases, including heart failure [9], cardiac arrhythmias [10][11][12][13], pulmonary hypertension [14,15], rheumatoid arthritis [16], Crohn's disease [17], and lupus [18]. The relatively recent discovery that the VN modulates the inflammatory response [19][20][21][22] might broaden the range of future indications for VNS, as inflammation is implicated in many common chronic diseases, such as type 2 diabetes, obesity, and atherosclerosis [23][24][25][26].…”

Auricular Intradermal Acupuncture as a Supplementary Motor Rehabilitation Strategy in Poststroke Patients: A Randomized Preliminary Clinical Study

“…Previous studies on VNS/taVNS stimulation have only reported improvement of the upper limb in poststroke patients, and they have not analyzed the effects on flexor or extensor synergy [7,8]. Our study makes an important contribution in this regard, as our results demonstrate improvement in both flexor and extensor synergy with AIA.…”

“…e brainstem, as a supraspinal center, plays an important role in maintaining posture and voluntary movement. Recently, emerging evidence indicated vagus nerve stimulation as well contributed to the increase of Fugl-Meyer assessment (FMA) on the upper limb after stroke [7,8]. Transcutaneous auricular branch vagus nerve stimulation (taVNS), a noninvasive alternative therapy, has similar benefits to invasive vagus nerve stimulation in terms of enhancing the effects of physiotherapy for upper limb motor recovery after stroke [7].…”