Quantitative Sensory Testing and Occipital Nerve Stimulator
Launched by BARTS & THE LONDON NHS TRUST · Sep 1, 2023
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a device called an Occipital Nerve Stimulator (ONS) might change the way patients with chronic migraines or cluster headaches experience pain. Researchers want to see if this device can make a difference in pain processing by comparing the results of patients who receive the ONS with those undergoing a non-painful procedure, like a dilation and curettage (D&C), and also with healthy volunteers. They will measure specific markers in the body that relate to pain perception before and after the ONS is implanted.
To participate in this study, you need to meet certain criteria. You should be an adult with chronic migraines or cluster headaches who qualifies for the ONS based on specific health guidelines. You also need to be able to understand and follow study procedures in English. However, if you are pregnant, have diabetes, or have certain medical conditions, you may not be eligible. If you choose to participate, you will be asked to complete questionnaires and follow up with the research team to help them understand how the ONS affects your pain.
Gender
ALL
Eligibility criteria
- • Inclusion criteria
- • Subject satisfies standard criteria in the study centre for ONS implantation and the NICE 452 criteria for intractable chronic migraine or cluster headache.
- • Patients who have given their written informed consent.
- • Patient is able and willing to comply with study procedures and follow up schedule.
- • Participants will need a good understanding of the English Language and hence. This is a requirement not just for this research but also for the success of the interventions and the full understanding of QST.
- • Patients undergoing surgery (non-painful complaint) 'dilatation and curettage' (D\&C).
- • Exclusion criteria
- • Any inclusion criteria not met
- • Female patients of childbearing age who is or plans on becoming pregnant during the course of the study
- • Patients with diabetes
- • Patients known to have a condition that in the investigator's judgment precludes participation in the study.
- • Patients who have received an investigational drug or have used an investigational device in the 30 days preceding to study entry
About Barts & The London Nhs Trust
Barts and The London NHS Trust is a leading healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality clinical care, research, and education. As a prominent sponsor of clinical trials, the Trust is dedicated to advancing medical knowledge and improving patient outcomes through innovative research initiatives. With a focus on patient safety and ethical standards, Barts and The London NHS Trust collaborates with multidisciplinary teams to explore cutting-edge therapies and interventions across various medical fields, ensuring that trial participants receive the highest level of care and support throughout their involvement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, , United Kingdom
Patients applied
Trial Officials
Vivek mehta, FRCA MD
Principal Investigator
Barts & The London NHS Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported