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

NCT07395908 | Active Not Recruiting DMC

• 1 other identifier: 2025/153
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Greater Occipital Nerve Block; Calcitonin Gene-related Peptide; Pacap-38; Chronic Migraine Headache; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (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.

  1 month

Secondary Outcomes (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.

  6 months

Study Arms (2)

patients to whom applied radiofrequency

EXPERIMENTAL

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 second

Procedure: Greater occipital nerve Pulse radiofrequency

patients to whom applied greater occipital nerve block

ACTIVE COMPARATOR

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.

Procedure: Greater occipital nerve block

Interventions

Greater occipital nerve block PROCEDURE

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.

patients to whom applied greater occipital nerve block

Greater occipital nerve 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 to whom applied radiofrequency

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Efeler / Aydın

Aydin, 09100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: May 29, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

TU (1)