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

Not Applicable

• Conditions: Stroke; Circulatory System

• Registration Number: ISRCTN20221867
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-07
• Last Update Posted: 18 September 2023
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 243

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper limb motor function assessed using the Upper Limb Fugl-Meyer (ULFM) total motor score at 3 months from the start of treatment