An efficacy and mechanism evaluation of transcutaneous vagal nerve stimulation for upper limb recovery post-stroke – a randomised, controlled, multi-arm, multi-stage, adaptive design trial

Sheffield Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 243 人开始时间: 2022年12月7日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•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

•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.

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