CompletedNot Applicable

Quantitative Sensory Testing and Occipital Nerve Stimulator

United Kingdom6 participantsStarted 2019-09-01

Plain-language summary

The primary aim of this study is to assess the reversibility of a range of psychophysical markers of pain processing in patients with chronic migraine or cluster headache before and after ONS insertion and comparing to patients having a general anaesthetic (GA) for a non-painful aetiology at Barts Health NHS Trust. We will also compare with healthy volunteers not undergoing surgery. To establish whether pain perception alters in patients with chronic migraine/cluster headache having ONS using questionnaires and compare to patients having a general anaesthetic for a non- painful procedure D \& C at Barts Health NHS Trust. Are pain markers (Glutamate, TGF-B1) altered with ONS?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with reversibility of a range of psychological markers of pain processing in patients with chronic migraine/cluster headache before and after ONS.

Timeframe: 4 WEEKS

Trial details

NCT IDNCT06022848

SponsorBarts & The London NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-14

View on ClinicalTrials.gov More Migraines trials