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Noninvasive vagal nerve stimulation for arm recovery after stroke

  • Research type

    Research Study

  • Full title

    Feasibility and acceptability of transcutaneous vagal nerve stimulation in recovery of upper limb function post stroke

  • IRAS ID

    186734

  • Contact name

    Jessica Redgrave

  • Contact email

    jessica.redgrave@sth.nhs.uk

  • Sponsor organisation

    Sheffield Teaching Hospitals NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    This study will find out whether electrical stimulation of a nerve called the “vagus” nerve is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20 patients will be recruited if they had a stroke between 4 and 48 months previously and have been left with reduced function in the affected arm. Patients will receive 3 sessions of physiotherapy per week for 6 weeks. Each session will last 1 hour during which the patient will be asked to perform specific movements e.g. shuffling cards, reaching for a shelf. With each arm movement the therapist will turn on a stimulator which is worn clipped to the patients ear. This will deliver a short burst of electricity creating a mild tingling sensation.
    At the end of the session, the stimulator will be removed and the patient will be asked to rate the level of any discomfort or fatigue they experienced as well as any other side effects. The therapist will also record whether the stimulator device interfered with the therapy in any way. A heart tracing will be performed at each visit to check the heart rhythm. At the start and end of the 6 week course of physiotherapy, patients arm weakness and level of arm function will be assessed, as well as their general levels of fatigue, mood and quality of life. These will be reassessed at 1 month and 6 months after the course of physiotherapy has ended. We will also interview patients to establish how they found the treatment itself. If the vagal nerve stimulation combined with physiotherapy is acceptable to patients and therapists and there are no safety concerns, we will plan a larger trial of this treatment in stroke patients.

  • REC name

    Yorkshire & The Humber - Sheffield Research Ethics Committee

  • REC reference

    15/YH/0397

  • Date of REC Opinion

    13 Oct 2015

  • REC opinion

    Further Information Favourable Opinion