NCT06834022

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

May 11, 2023

Last Update Submit

February 18, 2025

Conditions

Migraine

Keywords

tDCSacupunctureCGRPinflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

  • Number of days with migraine headache per month

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

    4 months

Secondary Outcomes (2)

  • Severity of migraine headache

    4 months

  • Change of inflammatory parameters

    4 months

Study Arms (4)

Sham Acupuncture

PLACEBO COMPARATOR

Patients receive sham acupuncture (skin remains intact, away from standard acupuncture points)

Procedure: Acupuncture

Verus Acupuncture

ACTIVE COMPARATOR

Patients receive acupuncture treatment over semistandardized acupuncture points for migraine headache.

Procedure: Acupuncture

Sham tDCS

PLACEBO COMPARATOR

Device will provide only placebo stimulation (study mode)

Device: Transcranial direct current stimulation

verus tDCS

ACTIVE COMPARATOR

Device will stimulate with direct current (study mode)

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

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

Sham tDCSverus tDCS
AcupuncturePROCEDURE

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

Sham AcupunctureVerus Acupuncture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital dr. Petra Držaja

Ljubljana, Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Transcranial Direct Current StimulationAcupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesComplementary Therapies

Study Officials

  • Manja Mlakar, MD

    University of Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

May 11, 2023

First Posted

February 19, 2025

Study Start

April 4, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

SL(1)