Quantitative Sensory Testing and Occipital Nerve Stimulator

NCT06022848 | Completed

• 1 other identifier: 210723
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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?

Conditions

Migraines

Outcome Measures

Primary Outcomes (1)

• 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.

  Change QST

  4 WEEKS

Secondary Outcomes (4)

• Percentage of participants with pain markers (glutamate, TGF-B1) altered with ONS

  12 months

• Number of participants whose functionality and quality of life following ONS - HIT6,

  4 weeks and 12 months

• The effect on functionality and quality of life following ONS - SF-12v2.

  4 weeks and 12 months

• The effect on functionality and quality of life following ONS - HAD

  4 weeks and 12 months

Study Arms (1)

Quantitative sensory testing

EXPERIMENTAL

Procedure: occipital nerve stimulator

Interventions

occipital nerve stimulator PROCEDURE

Quantitative sensory testing

Also known as: Quantitative sensory testing

Quantitative sensory testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts health NHS Trust

London, EC1A7BE, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vivek mehta, FRCA MD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: September 5, 2023
• Study Start: September 1, 2019
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)