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ENROLLING BY INVITATION
NCT06834022
NA

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

Sponsor: University Medical Centre Ljubljana

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-04-04

Completion Date

2025-12-01

Last Updated

2025-02-19

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Hospital dr. Petra Držaja

Ljubljana, Ljubljana, Slovenia