Neurostimulation in Intermittent Claudication

NCT06176898 | Unknown

• 1 other identifier: VS22/153016
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Claudication

Keywords

Vascular Medicine

Outcome Measures

Primary Outcomes (1)

• Maximal walking distance determined from the six-minute walk test

  Maximal walking distance determined from the six-minute walk test (6MWT)

  At baseline and at 8 weeks

Secondary Outcomes (2)

• Quality of life analysis using both generic and disease specific quality of life

  At baseline and at 8 weeks

• Patient acceptance of the neurostimulator device

  At baseline and at 8 weeks

Study Arms (1)

Neurostimulating device.

EXPERIMENTAL

Device: Neurostimulating device

Interventions

Neurostimulating device DEVICE

A trained practitioner will apply the neurostimulator to the patient's ear. The patient will wear the neurostimulator for a period of three week with the position of the neurostimulator moving from one ear to the other on a weekly basis. After 3 weeks the neurostimulator will be removed and the patient will then undergo further clinical assessment at week 8. At the 8 week clinical assessment, the patient will undergo the same assessments, namely: * Six minute walking test (6MWT) * Quality of life assessment using both generic (Short form 12) and disease specific (Vascuqol) questionnaires

Neurostimulating device.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rutherford b/c intermittent claudication with stable symptoms for 6 months with a decision not to undergo any revascularization.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patrick Coughlin, Yes

CONTACT

0113 392 8160; patrick.coughlin1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: December 20, 2023
• Study Start: June 26, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)