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Enrolling by Invitation

NCT Number: NCT06834022

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital dr. Petra Držaja

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

tDCS will be used according to instructions for use in migraine headache (supraorbital and M1 stimulation), 1 mA, 20 min, 10 sessions

Acupuncture

Procedure

Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions

Primary outcomes

  1. Number of days with migraine headache per month

    Time frame: 4 months

    Evaluation of migraine days before study, at 1 nad 3 months after comleted therapy.

Secondary outcomes

  1. Severity of migraine headache

    Time frame: 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

  2. Change of inflammatory parameters

    Time frame: 4 months

    Measurements of laboratory levels of IL-6, IL-8, IL-10, leptin before treatment and at 1 and 3 months after therapy

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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