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

NCT07395908 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-09

No results posted yet for this study

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

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

Interventions

PROCEDURE

Greater occipital nerve Pulse radiofrequency

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.

PROCEDURE

Greater occipital nerve 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.

Sponsors & Collaborators

  • Aydin Adnan Menderes University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07395908 on ClinicalTrials.gov