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

NCT06834022 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-02-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Manja Mlakar, MD · University of Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Slovenia

Study Locations

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Entities

Diseases

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 NCT06834022 on ClinicalTrials.gov