Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation
NCT ID: NCT06834022
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
120 participants
INTERVENTIONAL
2023-04-04
2025-12-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sham Acupuncture
Patients receive sham acupuncture (skin remains intact, away from standard acupuncture points)
Acupuncture
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
Verus Acupuncture
Patients receive acupuncture treatment over semistandardized acupuncture points for migraine headache.
Acupuncture
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
Sham tDCS
Device will provide only placebo stimulation (study mode)
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
verus tDCS
Device will stimulate with direct current (study mode)
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
Interventions
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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
Acupuncture
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
Eligibility Criteria
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Inclusion Criteria
* no acupuncture in the past
* understanding of study design and ability to give informed consent
Exclusion Criteria
* pacemaker
* status post brain surgery with open skull
* brain stimulators
* metal implants
* biologic drugs
* pregnancy
18 Years
65 Years
ALL
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Alenka Spindler-Vesel
MD, PhD, Principal Investigator
Principal Investigators
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Manja Mlakar, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ljubljana
Locations
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Hospital dr. Petra Držaja
Ljubljana, Ljubljana, Slovenia
Countries
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Other Identifiers
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0120-421/2022/3
Identifier Type: -
Identifier Source: org_study_id
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