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A Pivotal Randomized Study Assessing VNS During Rehabilitation

  • Research type

    Research Study

  • Full title

    A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB)

  • IRAS ID

    228128

  • Contact name

    W Brent Tarver

  • Contact email

    brent@microtransponder.com

  • Sponsor organisation

    MicroTransponder, Inc.

  • Clinicaltrials.gov Identifier

    NCT03131960

  • Duration of Study in the UK

    3 years, 11 months, 31 days

  • Research summary

    This study will be randomised, controlled and participant, assessor and therapist blinded. There will be approximately 60 participants per study group (120 total study patients; only about 15 per study group in the UK or about 30 total in the UK). We will include participants who have suffered an ischaemic stroke between nine (9) months and ten (10) years prior to enrollment and who have disability due to arm weakness. All subjects who complete baseline assessments will be implanted with the Vivistim System. Participants will be randomised to one of two treatment groups; the first group will receive intensive rehabilitation therapy (control) and the second will receive vagal nerve stimulation (VNS, investigational treatment) during their intensive rehabilitation therapy . VNS involves implantation of a device (similar to a cardiac pacemaker but that stimulates the vagus nerve in the neck rather than the heart). Stimulation of the vagus nerve may cause release of important chemicals in the brain which help the brain recover after stroke. The purpose of the study is to determine the efficacy and safety of this therapy (VNS + Rehabilitation). It is the intent that this study support a PMA application to the US FDA. Participants will be followed for blinded assessment of outcomes for 90 days. Longer-term follow-up will continue while the device is implanted.

    NOTE: Control subjects will receive VNS during rehabilitation after the randomized portion of the study (after V7, 90 days after the end of randomised therapy).

  • REC name

    West of Scotland REC 4

  • REC reference

    17/WS/0137

  • Date of REC Opinion

    3 Aug 2017

  • REC opinion

    Further Information Favourable Opinion