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

February 18, 2025 updated by: Alenka Spindler-Vesel, University Medical Centre Ljubljana

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Hospital dr. Petra Držaja

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sham Acupuncture
Patients receive sham acupuncture (skin remains intact, away from standard acupuncture points)
Procedure: Acupuncture
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
Active Comparator: Verus Acupuncture
Patients receive acupuncture treatment over semistandardized acupuncture points for migraine headache.
Procedure: Acupuncture
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
Placebo Comparator: Sham tDCS
Device will provide only placebo stimulation (study mode)
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
Active Comparator: verus tDCS
Device will stimulate with direct current (study mode)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Manja Mlakar, MD, University of Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-421/2022/3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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