Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study

Background. Transcutaneous auricular vagus nerve stimulation (taVNS) is regarded as a potential method for recovery in stroke. The effectiveness of taVNS in acute and subacute stroke should be further discussed as previously, only a few small-scale trials have focused on chronic stroke patients. The objective of this study is to investigate the effect and safety of taVNS on upper limb motor function in subacute ischemic stroke patients. Methods. Twenty-one subacute ischemia stroke patients with single upper limb motor function impairment were enrolled and randomly assigned to conventional rehabilitation training with real or sham taVNS, delivered for 15 consecutive days. Electrodes were fixed to the cymba conchae of the left ear with or without electrical stimulation. Conventional rehabilitation training was performed immediately after the end of real or sham taVNS by the same therapists. Baseline assessments were performed on day 0 of enrollment, and posttreatment evaluations were performed at 15 days, 4 weeks, and 12 weeks after the first intervention. The assessment included the upper limb Fugl-Meyer assessment (FMA-U), the Wolf motor function test (WMFT), the Functional Independence Measurement (FIM), and Brunnstrom stage. Heart rate (HR) and blood pressure (BP) were measured before and after each taVNS intervention. At the same time, any adverse effects were observed during the procedure. Outcomes were assessed by a blind evaluator. Results. There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline (P>0.05). At the endpoint, the FMA-U, WMFT, and FIM scores were significantly higher than before treatment (P<0.05), and there was a significantly greater improvement of those measurements in taVNS group compared with sham-taVNS group (P<0.05). Significant improvements in FMA-U score were found between groups at follow-up. Only one case of skin redness occurred during the study. Conclusions. This study revealed that taVNS appeared to be beneficial to the recovery of upper limb motor function in subacute ischemia stroke patients without obvious adverse effects. Trial registration. This trial is registered with ChiCTR1800019635 on 20 November 2018 (http://www.chictr.org.cn/showproj.aspx?proj=32961).

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Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial

The Lancet ◽

10.1016/s0140-6736(21)00475-x ◽

2021 ◽

Vol 397 (10284) ◽

pp. 1545-1553 ◽

Cited By ~ 1

Author(s):

Jesse Dawson ◽

Charles Y Liu ◽

Gerard E Francisco ◽

Steven C Cramer ◽

Steven L Wolf ◽

...

Keyword(s):

Ischaemic Stroke ◽

Vagus Nerve ◽

Motor Function ◽

Upper Limb ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation

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Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up

Neurorehabilitation and Neural Repair ◽

10.1177/1545968320924361 ◽

2020 ◽

Vol 34 (7) ◽

pp. 609-615

Author(s):

Jesse Dawson ◽

Navzer D. Engineer ◽

Cecília N. Prudente ◽

David Pierce ◽

Gerard Francisco ◽

...

Keyword(s):

Ischemic Stroke ◽

Vagus Nerve ◽

Upper Limb ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Exercise Program ◽

Home Exercise ◽

Home Exercise Program

Background. Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke. Objective. To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9). Methods. All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment—Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log. Results. There were no VNS treatment–related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P = .001; n = 15). Other functional measures were also improved at 1 year. Conclusions. VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.

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Vagus Nerve Stimulation Paired with Rehabilitation Improves Motor Function in Stroke Patients

Neurology Today ◽

10.1097/01.nt.0000755756.70685.76 ◽

2021 ◽

Vol 21 (11) ◽

pp. 1,11-12

Author(s):

Mark Moran

Keyword(s):

Vagus Nerve ◽

Motor Function ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Stroke Patients

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

European Stroke Journal ◽

10.1177/2396987319855306 ◽

2019 ◽

Vol 4 (4) ◽

pp. 363-377

Author(s):

Teresa J Kimberley ◽

Cecília N Prudente ◽

Navzer D Engineer ◽

David Pierce ◽

Brent Tarver ◽

...

Keyword(s):

Vagus Nerve ◽

Motor Function ◽

Study Protocol ◽

Upper Limb ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Randomised Study

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Vagus nerve stimulation for upper limb motor impairment after ischemic stroke

Medicine ◽

10.1097/md.0000000000027871 ◽

2021 ◽

Vol 100 (46) ◽

pp. e27871

Author(s):

Yu-lei Xie ◽

Shan Wang ◽

Qing Wu ◽

Xin Chen

Keyword(s):

Ischemic Stroke ◽

Vagus Nerve ◽

Upper Limb ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Motor Impairment

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An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke

Scientific Reports ◽

10.1038/s41598-019-52092-x ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 1

Author(s):

David Alexander Dickie ◽

Teresa Jacobson Kimberley ◽

David Pierce ◽

Navzer Engineer ◽

W. Brent Tarver ◽

...

Keyword(s):

Ischemic Stroke ◽

Vagus Nerve ◽

Upper Limb ◽

Nerve Stimulation ◽

Exploratory Study ◽

Vagus Nerve Stimulation ◽

Brain Mri ◽

Phase Iii ◽

Upper Limb Rehabilitation ◽

Limb Rehabilitation

Abstract We have previously shown the safety and feasibility of vagus nerve stimulation (VNS) paired with upper-limb rehabilitation after ischemic stroke. In this exploratory study, we assessed whether clinical and brain MRI variables predict response to treatment. We used data from two completed randomised and blinded clinical trials (N = 35). All participants had moderate to severe upper-limb weakness and were randomised to 6-weeks intensive physiotherapy with or without VNS. Participants had 3 T brain MRI at baseline. The primary outcome was change in Fugl-Meyer Assessment, upper-extremity score (FMA-UE) from baseline to the first day after therapy completion. We used general linear regression to identify clinical and brain MRI predictors of change in FMA-UE. VNS-treated participants had greater improvement in FMA-UE at day-1 post therapy than controls (8.63 ± 5.02 versus 3.79 ± 5.04 points, t = 2.83, Cohen’s d = 0.96, P = 0.008). Higher cerebrospinal fluid volume was associated with less improvement in FMA-UE in the control but not VNS group. This was also true for white matter hyperintensity volume but not after removal of an outlying participant from the control group. Responders in the VNS group had more severe arm impairment at baseline than responders to control. A phase III trial is now underway to formally determine whether VNS improves outcomes and will explore whether these differ in people with more severe baseline upper-limb disability and cerebrovascular disease.

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