Status:

RECRUITING

Quantitative Sensory Testing and Occipital Nerve Stimulator

Lead Sponsor:

Barts & The London NHS Trust

Conditions:

Migraines

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 insertio...

Detailed Description

Headache is one of the most common neurological problems accounting for 4% of primary care consultations and up to 30% of neurology appointments. Even though considerable advances in the understanding...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2025

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT06022848

    Start Date

    September 1 2019

    End Date

    November 1 2025

    Last Update

    May 13 2025

    Active Locations (1)

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    1

    Barts health NHS Trust

    London, United Kingdom, EC1A7BE