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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Acupuncture | Placebo Comparator | Patients receive sham acupuncture (skin remains intact, away from standard acupuncture points) |
|
| Verus Acupuncture | Active Comparator | Patients receive acupuncture treatment over semistandardized acupuncture points for migraine headache. |
|
| Sham tDCS | Placebo Comparator | Device will provide only placebo stimulation (study mode) |
|
| verus tDCS | Active Comparator | Device will stimulate with direct current (study mode) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with migraine headache per month | Evaluation of migraine days before study, at 1 nad 3 months after comleted therapy. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of migraine headache | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manja Mlakar, MD | University of Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital dr. Petra Držaja | Ljubljana | Ljubljana | 1000 | Slovenia |
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| Acupuncture | Procedure | Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions |
|
Measurements of laboratory levels of IL-6, IL-8, IL-10, leptin before treatment and at 1 and 3 months after therapy
| 4 months |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D000529 | Complementary Therapies |
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