MigraineNCT07170111
Predictors of GON Blockade Success in Migraine
A study testing Greater Occipital Nerve (GON) Blockade in people with Migraine, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Greater Occipital Nerve (GON) Blockade
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul
Tuba Tanyel Saraçoğlu, +90 212 909 60 00, tuba.saracoglu1@saglik.gov.tr
About this study
Official title: Predictive Factors for the Success of Greater Occipital Nerve Block in Migraine: A Multicenter Prospective Study
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
- Being tested
- Greater Occipital Nerve (GON) Blockade
- Keywords
- migraine, GON block, greater occipital nerve, greater occipital nerve block, predictive factors
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greater Occipital Nerve (GON) BlockadeProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| GON Block Group | Experimental | Not described Receives: Procedure: Greater Occipital Nerve (GON) Blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with headache
Measured: Baseline,1st month and 3rd month
Secondary outcomes (6)
The 6-Item Headache Impact Test (HIT-6)
The 6-Item Headache Impact Test (HIT-6) is a brief, validated questionnaire that assesses the adverse impact of headaches on daily functioning, with higher scores indicating greater impact.
Measured: Baseline,1st month and 3rd month
Global Rating of Change (GROC)
The Global Rating of Change (GROC) is a patient-reported scale that measures perceived change in health status over time, typically ranging from very much worse to very much improved.
Measured: 1st month and 3rd month
Numeric Rating Scale
A simple and widely used tool to assess pain intensity, where patients rate their pain on a scale from 0 to 10, with 0 meaning 'no pain' and 10 meaning 'the worst pain imaginable
Measured: Baseline,1st month and 3rd month
Number of migraine attacks
Measured: Baseline, 1st month and 3rd month
Duration of migraine attacks
Measured: Baseline, 1st month and 3rd month
Analgesic consumption
Measured: Baseline, 1st month and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Umraniye Education and Research Hospital, Gaziantep City Hospital, Namik Kemal University School of Medicine, Tekirdag, Bakırçay University, Faculty of Medicine
- Responsible party
- Principal investigator, Tuba Tanyel Saraçoğlu, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170111
- Sponsor's protocol ID
- 25.06.2025.242
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for the Success of Greater Occipital Nerve Block in Migraine: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07170111
- Acronym / sponsor ID
- 25.06.2025.242
- Conditions
- Migraine
- Keywords
- migraine, GON block, greater occipital nerve, greater occipital nerve block, predictive factors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Umraniye Education and Research Hospital, Gaziantep City Hospital, Namik Kemal University School of Medicine, Tekirdag, Bakırçay University, Faculty of Medicine
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GON Block Group | Experimental | Procedure: Greater Occipital Nerve (GON) Blockade |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greater Occipital Nerve (GON) BlockadeThe 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 | Procedure or surgery | GON Block Group |
Primary outcome
Number of days with headache
Time frame: Baseline,1st month and 3rd month
6 secondary outcomes
The 6-Item Headache Impact Test (HIT-6)
Time frame: Baseline,1st month and 3rd month
Global Rating of Change (GROC)
Time frame: 1st month and 3rd month
Numeric Rating Scale
Time frame: Baseline,1st month and 3rd month
Number of migraine attacks
Time frame: Baseline, 1st month and 3rd month
Duration of migraine attacks
Time frame: Baseline, 1st month and 3rd month
Analgesic consumption
Time frame: Baseline, 1st month and 3rd month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greater Occipital Nerve (GON) Blockade in people with Migraine, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Tanyel Saraçoğlu (+90 212 909 60 00, tuba.saracoglu1@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with headache (time frame: Baseline,1st month and 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.