Quantitative Sensory Testing and Occipital Nerve Stimulator

Launched by BARTS & THE LONDON NHS TRUST · Sep 1, 2023

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