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

Not Applicable

• Conditions: Migraine

• Registration Number: NCT06834022
• Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-04
• Study First Submitted: 2023-05-11
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 4 migraine days per month
• no acupuncture in the past
• understanding of study design and ability to give informed consent

Exclusion Criteria

• severe psychiatric disorders
• pacemaker
• status post brain surgery with open skull
• brain stimulators
• metal implants
• biologic drugs
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of days with migraine headache per month	4 months	Evaluation of migraine days before study, at 1 nad 3 months after comleted therapy.

Secondary Outcome Measures

Name	Time	Method
Severity of migraine headache	4 months	Evaluation of HIT and MIDAS questionnaire before study and 1 and 3 months after completed therapy.; CGRP levels before and after 1 and 3 months after completed therapy
Change of inflammatory parameters	4 months	Measurements of laboratory levels of IL-6, IL-8, IL-10, leptin before treatment and at 1 and 3 months after therapy

Trial Locations

Locations (1)

Hospital dr. Petra Držaja; 🇸🇮 Ljubljana, Slovenia