NCT06834022

Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare effects of the treatment with acupuncture and transcranial direct current stimulation (tDCS) in patients with migraine headache. The main questions it aims to answer are: * is tDCS more effective than acupuncture/placebo? * is there any difference in venous blood inflammatory parameters (CGRP (calcitonin gene related peptide), IL (interleukine) -6, IL-8. IL-10, SAA (serum amyloid A) and ESR (erythrocyte sedimentation rate) before/after treatment? * could these inflammatory parameters function as biomarkers of disease and/or indicators of treatment's efficacy? Participants will regularly fill out questionnaires (migraine diary) and their venous blood before/after treatment will be taken for analysis. Researchers will compare the effects of sham and verus treatment of both methods before and after treatment.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation	tDCS will be used according to instructions for use in migraine headache (supraorbital and M1 stimulation), 1 mA, 20 min, 10 sessions
PROCEDURE	Acupuncture	Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

1 site across 1 country: Slovenia