Migraine
Conditions
Keywords
tDCS, acupuncture, CGRP, inflammatory biomarkers
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.
Interventions
DEVICETranscranial 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
PROCEDUREAcupuncture
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with migraine headache per month | 4 months | Evaluation of migraine days before study, at 1 nad 3 months after comleted therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of migraine headache | 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 |
| Change of inflammatory parameters | 4 months | Measurements of laboratory levels of IL-6, IL-8, IL-10, leptin before treatment and at 1 and 3 months after therapy |
Countries
Slovenia
Outcome results
None listed