Stroke Circulatory System
Conditions
Interventions
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
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Has significant other impairment of upper limb, e.g., frozen shoulder 2. Has severe spasticity (Modified Ashworth score of =3) 3. Has health conditions that prevent engagement with rehabilitation therapy, e.g., advanced dementia 4. Has severe aphasia and either: a) informed consent unlikely based on consent support tool, b) engagement with RTT difficult, or c) inability to communicate adverse events from TVNS 5. Currently participating in another stroke rehabilitation trial 6. Pregnant or trying to get pregnant 7. On a pacemaker or another implantable electrical device 8. Has a cochlear implant or other similar device 9. Currently receiving therapy or treatment to improve arm function and would not be willing to stop for the duration of the trial 10. Has previously experienced a haemorrhagic stroke For all participants entering the mechanistic sub-study only: 1. Contraindications to Magnetic Resonance Imaging (MRI) (e.g., metal implant) 2. Has previously experienced or is likely to suffer severe anxiety or claustrophobia in relation to MR imaging examination Additional criteria for PET-MRI: 1. Contraindications to Positron Emission Tomography (PET) (e.g., has a known allergy to FDG PET tracer) 2. Has unstable diabetes A full screening assessment will be conducted when the participant attends for the MRI to ensure the safety of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper limb motor function assessed using the Upper Limb Fugl-Meyer (ULFM) total motor score at 3 months from the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Index for 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 | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed