A trial investigating the effectiveness of vagus nerve stimulation during rehabilitation therapy in patients with a weak arm following a stroke

INTERVENTION: Participants will be allocated to receive TVNS plus self‐delivered rehabilitation therapy for 1 hour, 5 times a week for 12 weeks, or sham TVNS (the earpiece will produce negligible stimulation) plus self‐delivered rehabilitation therapy for 1 hour, 5 times a week for 12 weeks. Some participants may also be asked to wear the device whilst doing activities of daily living for 1 to 8 hours on the therapy days. CONDITION: Stroke ; Circulatory System PRIMARY OUTCOME: Upper limb motor function assessed using the Upper Limb Fugl‐Meyer (ULFM) total motor score at 3 months from the start of treatment SECONDARY OUTCOME: ; Measured at baseline, 3 and 6 months from the start of treatment, unless stated otherwise:; 1. Upper limb motor function assessed using the ULFM total motor score at 6 months from the start of treatment; 2. Sensation, joint range of motion and joint pain assessed using other components of the ULFM outcome measure; 3. Motor function of the affected arm assessed using the Wolf Motor Function Test (WMFT); 4. Total stroke‐related neurological deficit measured using the Modified National Institute of Health Stroke Scale (mNIHSS); 5. The degree of dependence in the daily activities of people who have had a stroke, measured using the Modified Rankin Scale (mRS); 6. Activities of daily living assessed using the Nottingham Extended Activities of Daily Living (NEADL) scale; 7. Stroke‐specific quality of life measured using the Stroke‐Specific Quality‐of‐Life (SS‐QOL) scale; 8. Generalised anxiety disorder assessed using the General Anxiety Disorder (GAD‐7) total score; 9. Depression assessed using the Patient Health Questionnaire (PHQ‐9) total score; 10. Fatigue assessed using the Neurological Fatigue Inde Xfor stroke (NFI‐Stroke); 11. Pain intensity measured using a Visual Analogue Scale (VAS); 12. Whether a participant had experienced a clinically meaningful improvement of 6 points on ULFM total motor score outcome compared to baseline; INCLUSION CRITERIA: 1. Aged 18 years or greater 2. Anterior circulation ischaemic stroke between 6 months and 10 years previously 3. Baseline ULFM of 20‐50 (inclusive) indicating moderate to severe arm dysfunction 4. At least 10 degrees of active wrist extension, 10 degrees of active thumb abduction/extension, and 10 degrees of active extension in at least 2 additional digits 5. Able to participate in rehabilitation therapy, provide feedback on adverse events (AEs), and give appropriate informed consent based on clinical judgment