Predictors of GON Blockade Success in Migraine

NCT07170111 | Not Yet Recruiting

• 1 other identifier: 25.06.2025.242
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, prospective cohort study aims to identify clinical and demographic predictors that influence the success of greater occipital nerve (GON) block in patients with migraine. Patients will be evaluated at baseline, on each injection day, and at one- and three-month follow-ups. Study parameters include demographics, migraine type and duration, comorbidities, headache characteristics, treatment history, and validated outcome measures such as the Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6), and Global Rating of Change (GRoC). The goal is to establish predictive factors of treatment success in order to optimize patient selection and contribute robust multicenter evidence to individualized migraine management

Conditions

Migraine

Keywords

migraine; GON block; greater occipital nerve; greater occipital nerve block; predictive factors

Outcome Measures

Primary Outcomes (1)

• Number of days with headache

  Baseline,1st month and 3rd month

Secondary Outcomes (6)

• The 6-Item Headache Impact Test (HIT-6)

  Baseline,1st month and 3rd month

• Global Rating of Change (GROC)

  1st month and 3rd month

• Numeric Rating Scale

  Baseline,1st month and 3rd month

• Number of migraine attacks

  Baseline, 1st month and 3rd month

• Duration of migraine attacks

  Baseline, 1st month and 3rd month

Study Arms (1)

GON Block Group

EXPERIMENTAL

Procedure: Greater Occipital Nerve (GON) Blockade

Interventions

Greater Occipital Nerve (GON) Blockade PROCEDURE

The greater occipital nerve block (GONB) will be performed using anatomical landmarks (distal approach). The injection point is located at the medial one-third of the line between the external occipital protuberance and the mastoid process. A 26-gauge insulin needle will be used for the procedure. The block will be administered bilaterally with 0.5% bupivacaine, 1.5 ml per side (total 3 ml). The intervention will be repeated once weekly for a total of four sessions

GON Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of migraine for at least 6 months, according to ICHD-3 criteria
• Age between 18 and 65 years
• Inadequate response to preventive therapy used regularly for at least 3 months
• Planned treatment with greater occipital nerve block (GONB) and provision of signed informed consent
• Receiving GONB treatment for the first time

You may not qualify if:

• Pregnancy or breastfeeding
• Presence of malignancy
• Coagulopathy or anticoagulant therapy
• Local infection, open wound, or history of surgery at the injection site preventing the procedure
• History of severe neurological or psychiatric disorders
• Receipt of interventional treatment (e.g., Botox, acupuncture, neural therapy, nerve blocks) within the last 3 months
• Use of steroids or immunosuppressive therapy
• Start of a new preventive therapy within the last 3 months
• Inability to comply with keeping a headache diary
• Known hypersensitivity or allergy to bupivacaine

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead
• Umraniye Education and Research Hospital: collaborator
• Gaziantep City Hospital: collaborator
• Namik Kemal University School of Medicine, Tekirdag: collaborator
• Bakırçay University, Faculty of Medicine: collaborator

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tuba Tanyel Saraçoğlu

CONTACT

+90 212 909 60 00; tuba.saracoglu1@saglik.gov.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 12, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)