VANS
Research type
Research Study
Full title
Vagal Autonomic Neuromodulation by transcutaneous nerve stimulation in acute ischaemic Stroke requiring mechanical thrombectomy: a phase 2A, sham controlled randomised trial
IRAS ID
314067
Contact name
Gareth Ackland
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
Removing blood clots from the brain by mechanical thrombectomy has revolutionised the management of stroke, but more than 50% of patients do not regain functional independence. Blood pressure (BP) control is important, since low and high BP are strongly associated with poor patient outcomes after thrombectomy. Intact autonomic function is required to control BP and potentially improve recovery after stroke. Impairment of baroreflex autonomic function, due to reduced vagal activity is associated with extreme BP variability, leading to further brain injury and cardiovascular complications. Reduced baroreflex control is related to poor patient outcomes after stroke, independent of absolute blood pressure. Reversing baroreflex and vagal dysfunction is, therefore, widely held to have the potential to improve cardiovascular control and patient outcome in this context.
Vagal nerve stimulation improves autonomic control and reverses baroreflex dysfunction but this has previously required surgically implanted devices which are expensive and impractical in the context of acute stroke. Afferent Electronic have achieved the same effect as these implantable devices by non-invasive transcuTANeous autonomic neuromodulation (TAN). Our investigational device might be an improvement on currently available pharmacological treatments, since it is non-pharmacological and is readily accessible to all patients including after discharge from hospital. Compliance with device use can be monitored remotely to optimize therapeutic effect. We will examine the effect of TAN versus sham stimulation to ensure any effects are not attributable to placebo effect. The intervention has no impact on standard of care with other (pharmacological) therapies.
REC name
Wales REC 6
REC reference
23/WA/0013
Date of REC Opinion
16 Mar 2023
REC opinion
Further Information Favourable Opinion