Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation

University Medical Centre Ljubljana

Status: Invitation-only

Conditions: Migraine

Treatments: Device: Transcranial direct current stimulation; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06834022

0120-421/2022/3

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Sham Acupuncture

Placebo Comparator group

Description:

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

Treatment:

Procedure: Acupuncture

Verus Acupuncture

Active Comparator group

Description:

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

Treatment:

Procedure: Acupuncture

Sham tDCS

Placebo Comparator group

Description:

Device will provide only placebo stimulation (study mode)

Treatment:

Device: Transcranial direct current stimulation

verus tDCS

Active Comparator group

Description:

Device will stimulate with direct current (study mode)

Treatment:

Device: Transcranial direct current stimulation