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Chronic Migraine HeadacheNCT07395908

The Effect of Interventional Procedures on Serum CGRP and PACAP-38 Levels in Chronic Migraine

A study testing Greater occipital nerve Pulse radiofrequency and Greater occipital nerve block in people with Chronic Migraine Headache and Radiofrequency Ablation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study included 100 patients diagnosed with chronic migraine (CM) who received a diagnosis from the headache clinics of the Neurology Department of Adnan Menderes University Hospitals between May 2025 and May 2026. Inclusion criteria were patients over 18 years of age with chronic migraine. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Greater occipital nerve Pulse radiofrequency and Greater occipital nerve block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 May 2025to Jun 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Being over 18 years of age
  • Having given written consent
  • Patients diagnosed with chronic migraine

Who cannot join

  • Major psychiatric illness
  • Patients using anticoagulant agents
  • 4. Patients with infection in the procedure area 5. Patients allergic to local anesthetics 6. Pregnant women 7. Patients with cardiac pacemakers

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Adnan Menderes University Efeler / Aydın

    Aydin, 09100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of Trigeminocervical Complex Peripheral Branch Blockade and Neuromodulation Methods With Peripheral Blood CGRP and PACAP38 Levels in Patients With Chronic Migraine

The study included 100 patients diagnosed with chronic migraine (CM) who received a diagnosis from the headache clinics of the Neurology Department of Adnan Menderes University Hospitals between May 2025 and May 2026. Inclusion criteria were patients over 18 years of age with chronic migraine. Written informed consent was obtained from all participants; patients with severe systemic diseases, occiput infections or injuries, and allergies to any of the substances used in the injection were excluded. All patients were clinically evaluated (detailed history including personal data, medical history, and migraine treatments used). All patients underwent ultrasound-guided bilateral GON blockade using a portable ultrasound system with a 7-13 MHz multifrequency transducer (ACUSON Juniper Ultrasound System, Siemens, Germany). Blood samples were collected before and one month after the procedure. Samples were collected between 9 and 11 am to avoid the effect of circadian rhythms on CGRP levels. Patients will need to discontinue any anti-inflammatory or analgesic medication within the last 48 hours. A blood sample will be taken from the non-dominant forearm to measure interictal serum CGRP-PACAP38 levels using commercial ELISA kits (Novus Biologicals Inc., USA) according to the manufacturer's instructions. Absorption levels will be measured with a spectrophotometer at a wavelength of 450 nm ± 2 nm. The detection limit for CGRP is 9.3 pg/mL.

Read the detailed description

Preoperative Visit:

During the preoperative visit, patients' additional illnesses, demographic data, and medication use will be recorded. The patients' NRS (Numerating Rating Scale) score will be recorded. Antebrachial venous blood samples will be taken along with routine samples requested after the outpatient examination.

Intraoperative Nerve Block Procedure:

All procedures were planned to be performed under sterile conditions with ultrasound guidance while the patient was in the prone position.

GON Block: The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.

Intraoperative Pulse Radiofrequency procedure:

For radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 seconds.

Patients will be observed after the procedure. Patients who do not experience postoperative complications and are mobile will be discharged at 2 hours. Patients may withdraw from the study at any time.

Patients meeting the eligibility criteria will be informed in detail about the procedure. Written and verbal consent will be obtained from the patients.

Post-operative visits:

Venous blood sampling will be performed one month after the procedure, along with routine samples requested after the outpatient examination.

Samples were collected between 9 and 11 a.m. to avoid the influence of circadian rhythms on CGRP levels. Subjects were required to discontinue any anti-inflammatory or analgesic medication in the previous 48 hours. Blood samples were taken from the non-dominant forearm to measure interictal serum CGRP levels using commercial ELISA kits (Novus Biologicals Inc., USA) following the manufacturer's instructions. Absorption levels were measured with a spectrophotometer at a wavelength of 450 nm to 2 nm. The detection limit of the test was considered to be 9.3 pg/ml for CGRP.

For PACAP 38, blood samples were collected into ice-cold glass tubes containing the anticoagulant ethylenediaminetetraacetic acid (EDTA, 12 mg) and the protease inhibitor aprotinin (Trasylol, 1200 IU) and kept at 4°C until centrifuged (2000 rpm for 10 minutes at 4°C). Plasma samples will be stored at -80°C until measured by PACAP-38.

Pain intensity will be assessed using the NRS (Numerical Rating Scale) at 1, 3, and 6 months post-procedure.

The NRS is a pain intensity assessment system based on a system where the individual describes their pain on a scale of 0 (none) to 10 (unbearable pain).

Being tested
Greater occipital nerve Pulse radiofrequency, Greater occipital nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Greater occipital nerve Pulse radiofrequencyProcedure or surgery

    For radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 seconds.

  • Greater occipital nerve blockProcedure or surgery

    The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.

Study groups in NCT07395908
Study groupRoleWhat they receive
patients to whom applied radiofrequencyExperimentalFor radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 second
Receives: Procedure: Greater occipital nerve Pulse radiofrequency
patients to whom applied greater occipital nerve blockActive comparatorThe ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.
Receives: Procedure: Greater occipital nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The aim of this study is to investigate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine using biochemical migraine biomarkers

    It was planned to measure venous blood CGRP and PACAP38 levels in patients with chronic migraine before the interventional procedure and one month after the procedure.

    Measured: 1 month

Secondary outcomes (1)
  1. The secondary outcome of this study is to compare the effectiveness of nerve block and radiofrequency treatments on chronic pain in patients with chronic migraine.

    To evaluate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine, a numerical rating scale (NRS) was planned to be applied before the procedure, and at 1, 3, and 6 months after the procedure. An NRS reduction of 50% or more was considered significant.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start29 May 2025
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395908
Sponsor's protocol ID
2025/153
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Greater occipital nerve Pulse radiofrequency and Greater occipital nerve block in people with Chronic Migraine Headache and Radiofrequency Ablation, run by Aydin Adnan Menderes University 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The aim of this study is to investigate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine using biochemical migraine biomarkers (time frame: 1 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 9 Feb 2026.

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