Title: Transcutaneous auricular vagus nerve stimulation (tVNS) for upper limb motor recovery in chronic stroke.
Funder: Stroke Association

Abstract: Central Research Question How does transcutaneous vagus nerve stimulation (tVNS) paired with physiotherapy affect motor function in chronic stroke and are there biomarkers that can predict the treatment response? Key Aims: (1) To characterise the effect of tVNS paired with physiotherapy on cortical representation of the affected upper limb and cerebral connectivity, blood flow and metabolism. (2) To identify whether tVNS changes serum markers of inflammation, neurogenesis, and angiogenesis. Methodology: This proposal is a mechanistic sub-study of a NIHR-funded multi-centre clinical trial investigating the efficacy of tVNS in upper limb motor recovery in stroke. Forty participants with an ischaemic stroke > 9 months prior and persistent moderate-severe arm weakness will be randomised to tVNS with home physiotherapy or sham tVNS with home physiotherapy for 12 weeks. Active tVNS will be delivered by the NEMOS stimulator (TVNS Technologies, Germany) and will be activated by arm movement detected by a smart wristband. The primary outcome is improvement in arm motor function at 3 months. All participants in Sheffield (20 active, 20 sham) will have structural and fMRI imaging and serum marker analysis at baseline and 3 months. Twenty participants (10 active, 10 sham) will also have 18F-FDG PET-MRI at baseline and 3 months. Implications: The proposed study aims to characterise the neuro-anatomical, metabolic, and serological basis of a novel therapy that shows promising evidence as a potential treatment for arm weakness after stroke. This has several potential implications for further research and clinical practice including optimising the dose and duration of therapy. Lay summary (maximum 250 words, explain to a lay audience t

Lay abstract: Central Research Question How does transcutaneous vagus nerve stimulation (tVNS) paired with physiotherapy affect motor function in chronic stroke and are there biomarkers that can predict the treatment response? Key Aims: (1) To characterise the effect of tVNS paired with physiotherapy on cortical representation of the affected upper limb and cerebral connectivity, blood flow and metabolism. (2) To identify whether tVNS changes serum markers of inflammation, neurogenesis, and angiogenesis. Methodology: This proposal is a mechanistic sub-study of a NIHR-funded multi-centre clinical trial investigating the efficacy of tVNS in upper limb motor recovery in stroke. Forty participants with an ischaemic stroke > 9 months prior and persistent moderate-severe arm weakness will be randomised to tVNS with home physiotherapy or sham tVNS with home physiotherapy for 12 weeks. Active tVNS will be delivered by the NEMOS stimulator (TVNS Technologies, Germany) and will be activated by arm movement detected by a smart wristband. The primary outcome is improvement in arm motor function at 3 months. All participants in Sheffield (20 active, 20 sham) will have structural and fMRI imaging and serum marker analysis at baseline and 3 months. Twenty participants (10 active, 10 sham) will also have 18F-FDG PET-MRI at baseline and 3 months. Implications: The proposed study aims to characterise the neuro-anatomical, metabolic, and serological basis of a novel therapy that shows promising evidence as a potential treatment for arm weakness after stroke. This has several potential implications for further research and clinical practice including optimising the dose and duration of therapy. Lay summary (maximum 250 words, explain to a lay audience t

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: STROKE