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Lancet (London, England) Apr 2021Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke.
METHODS
In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the UK and the USA, participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by ResearchPoint Global (Austin, TX, USA) using SAS PROC PLAN (SAS Institute Software, Cary, NC, USA), with stratification by region (USA vs UK), age (≤30 years vs >30 years), and baseline Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score (20-35 vs 36-50). Participants, outcomes assessors, and treating therapists were masked to group assignment. All participants were implanted with a vagus nerve stimulation device. The VNS group received 0·8 mA, 100 μs, 30 Hz stimulation pulses, lasting 0·5 s. The control group received 0 mA pulses. Participants received 6 weeks of in-clinic therapy (three times per week; total of 18 sessions) followed by a home exercise programme. The primary outcome was the change in impairment measured by the FMA-UE score on the first day after completion of in-clinic therapy. FMA-UE response rates were also assessed at 90 days after in-clinic therapy (secondary endpoint). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT03131960.
FINDINGS
Between Oct 2, 2017, and Sept 12, 2019, 108 participants were randomly assigned to treatment (53 to the VNS group and 55 to the control group). 106 completed the study (one patient for each group did not complete the study). On the first day after completion of in-clinic therapy, the mean FMA-UE score increased by 5·0 points (SD 4·4) in the VNS group and by 2·4 points (3·8) in the control group (between group difference 2·6, 95% CI 1·0-4·2, p=0·0014). 90 days after in-clinic therapy, a clinically meaningful response on the FMA-UE score was achieved in 23 (47%) of 53 patients in the VNS group versus 13 (24%) of 55 patients in the control group (between group difference 24%, 6-41; p=0·0098). There was one serious adverse event related to surgery (vocal cord paresis) in the control group.
INTERPRETATION
Vagus nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after ischaemic stroke.
FUNDING
MicroTransponder.
Topics: Aged; Case-Control Studies; Combined Modality Therapy; Exercise Therapy; Female; Humans; Implantable Neurostimulators; Ischemic Stroke; Male; Middle Aged; Outcome Assessment, Health Care; Paresis; Recovery of Function; Stroke Rehabilitation; Treatment Outcome; Upper Extremity; Vagus Nerve Stimulation; Vocal Cord Paralysis
PubMed: 33894832
DOI: 10.1016/S0140-6736(21)00475-X -
Ugeskrift For Laeger Nov 2022Injection augmentation of the vocal cords is a recognized treatment modality in patients with glottal closure deficiency caused by paresis or paralysis of the vocal... (Review)
Review
Injection augmentation of the vocal cords is a recognized treatment modality in patients with glottal closure deficiency caused by paresis or paralysis of the vocal cord. The treatment can improve voice quality and also quality of life. It is preferable to minimize waiting time for the procedure for patients with lung cancer and mediastinal involvement, because the one-year mortality is above 40%, as argued in this review.
Topics: Humans; Vocal Cords; Quality of Life; Mediastinum; Lung Neoplasms; Palliative Care
PubMed: 36426831
DOI: No ID Found -
Ear, Nose, & Throat Journal Aug 2022Vocal fold paralysis (VFP) can result from a variety of diseases or surgeries and has various causes. This study determined concurrent etiologies in patients who were...
BACKGROUND
Vocal fold paralysis (VFP) can result from a variety of diseases or surgeries and has various causes. This study determined concurrent etiologies in patients who were treated in a teaching hospital (tertiary medical center).
METHODS
A retrospective review of medical records of patients with VFP from September 2010 to December 2019 was performed to determine the etiology. Patients with laryngeal/hypopharyngeal malignancies, those with incomplete examination and follow-up data were excluded from the study. During the follow-ups, cases involving recovery were also excluded.
RESULTS
One hundred and ninety-four patients with a determined etiology were included: 113 males and 81 females. Unilateral VFP was present in 178 patients, and 16 presented with bilateral VFP. The causes of unilateral VFP were surgical for 61.3%, neoplastic for 17.5%, idiopathic for 10.3%, traumatic for 1.5%, central for 4.7%, cardiovascular for 2%, radiation-induced for 1.5%, and inflammatory for 1%. Thyroidectomy was the most common surgery for unilateral VFP and was the cause for 54 patients. Lung cancer was responsible for 15 cases and was the most common neoplastic etiology of unilateral VFP. For those who presented with bilateral VFP, surgery was the most common cause and accounted for 56.3% of the incidences. In terms of gender, surgery was the most common cause for both sexes, accounting for 62 of 113 male patients and 57 of 81 female patients. Four cases recovered during the follow-ups and these were excluded.
CONCLUSION
Surgery and in particular, thyroidectomy, was the most common cause of VFP for these series. Central nervous system disorders were the cause of VFP (4.5%). Central nervous system disorders, especially cerebrovascular accidents that induced VFP, could not be neglected. Radiation-induced cranial nerve paralysis in the head and neck cancer was possible causes. The percentage for the causes of unilateral VFP, surgery increased and the percentage for neoplasm decreased for Taiwan.
Topics: Cranial Nerve Diseases; Female; Humans; Laryngeal Neoplasms; Male; Retrospective Studies; Thyroidectomy; Vocal Cord Paralysis; Vocal Cords
PubMed: 33090900
DOI: 10.1177/0145561320965212 -
Brazilian Journal of Otorhinolaryngology 2020
Topics: Aged; Humans; Injections, Intralesional; Laryngoplasty; Meta-Analysis as Topic; Secondary Prevention; Treatment Outcome; Vocal Cord Paralysis
PubMed: 31892508
DOI: 10.1016/j.bjorl.2019.11.001