Neurostimulation in intermittent claudication
Research type
Research Study
Full title
The effect of neurostimulation on patient relevant outcomes in patients with intermittent claudication: a pilot study.
IRAS ID
257802
Contact name
Patrick Coughlin
Contact email
Sponsor organisation
Research & Innovation department
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Intermittent claudication is a condition where a patient suffers with cramp-like pain experienced in the muscles of the legs (often the calf muscles) brought on by walking and relieved by stopping walking and resting. It is caused by furring of the arteries (atherosclerosis) often referred to as a circulation problem. It has a significant effect on a sufferers' quality of life. However, in 75% of patients with this condition, the leg symptoms will either stay static or improve slightly even with no treatment. The first line treatment is enrolment in an exercise / walking programme but these are not widely available on the NHS. Failing this, minimally invasive treatment - opening up the narrowing of the artery with either a balloon or stent - can be performed but they are not without risk (being an invasive treatment) and the narrowing often reoccurs in time. Due to the benign natural history of the leg, surgery is less frequently being used. This therefore leaves us with a large number of patients with symptoms with no treatment options and thus a poorer quality of life. Neurostimulation has been used to treat a number of neurological conditions. This study will use a specific device that is attached to the outer aspect of the ear to deliver a neurostimulation to a small branch of the Vagus nerve which through nerve pathways that course through the brain is believed to improve the blood supply to the lower legs.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
23/SW/0070
Date of REC Opinion
17 May 2023
REC opinion
Favourable Opinion