Assessing pain processing changes in migraine patients with occipital nerve stimulation
Does Occipital Nerve Stimulation Alter Pain Response as Measured by Quantitative Sensory Testing in Patients With Chronic Migraine or Cluster Headache
This study is testing how inserting an occipital nerve stimulator affects pain perception in people with chronic migraines or cluster headaches compared to those having a non-painful procedure and healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06022848 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how pain perception changes in patients with chronic migraines or cluster headaches before and after the insertion of an occipital nerve stimulator (ONS). It will compare these changes to patients undergoing a non-painful procedure under general anesthesia and to healthy volunteers. The study will utilize questionnaires and measure specific pain markers to assess the effects of ONS on pain processing. The research is conducted at Barts Health NHS Trust, focusing on understanding the underlying mechanisms of chronic headache disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with intractable chronic migraines or cluster headaches who meet the criteria for ONS implantation.
Not a fit: Patients with conditions that preclude participation, such as diabetes or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients suffering from chronic migraines and cluster headaches.
How similar studies have performed: While neurostimulation techniques have been explored in other studies, this specific approach assessing pain processing changes with ONS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- Barts health NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Vivek mehta, FRCA MD — Barts & The London NHS Trust
- Study coordinator: Theresa Wodehoise
- Email: theresa.wodehouse@nhs.net
- Phone: 07866813990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.