Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial direct current stimulation, Acupuncture.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 - Procedure Acupuncture
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
Primary outcome measures
- Number of days with migraine headache per month [Time frame: 4 months]
Secondary outcome measures (2)
- Severity of migraine headache [Time frame: 4 months]
- Change of inflammatory parameters [Time frame: 4 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- Hospital dr. Petra Držaja — Ljubljana
Identifiers
NCT: NCT06834022 · 0120-421/2022/3