Neurostimulation in Intermittent Claudication

Launched by THE LEEDS TEACHING HOSPITALS NHS TRUST · Dec 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called neurostimulation for people with intermittent claudication, a condition that causes painful cramps in the legs when walking. This pain usually goes away when you stop and rest. The trial will use a device placed on the outside of the ear to send gentle electrical signals to a nerve that may help improve blood flow to the legs. This could potentially make walking easier and improve the quality of life for those who suffer from this condition.

To participate in the trial, you should have been experiencing stable symptoms of intermittent claudication for at least six months and have chosen not to undergo surgery to open up the arteries. Unfortunately, if you have severe circulation issues, have had ear surgery, or have certain medical devices like a cochlear implant or pacemaker, you won't be eligible. If you do join the study, you can expect to receive the neurostimulation treatment and be monitored by the medical team throughout the trial. This research could provide valuable insights into new ways to help people with claudication manage their symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Rutherford b/c intermittent claudication with stable symptoms for 6 months with a decision not to undergo any revascularization.
• Exclusion Criteria:
• • • Critical limb ischaemia
• • Previous external ear surgery
• • Patients with either a cochlear implant or a permanent pacemaker / cardiac defibrillator device
• • Significant cardiorespiratory or musculoskeletal disease (as determined by the medical team) that would contraindicate a 6-minute walk test