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NCT Number: NCT07292506

The Impact of Acupuncture on Biomarkers of Brain Injury and Inflammatory Response in Migraine

Migraine is more than just a headache-it can involve changes in the brain and inflammation. Recent research suggests that acupuncture may help by calming pain signals and reducing inflammation in the body. Scientists are studying whether acupuncture can also lower certain markers in the blood that show brain stress or inflammation. While more research is needed, acupuncture is considered safe and may reduce the number and severity of migraine attacks for many people. Acupuncture has been used for over 40 years in our practice to manage acute and chronic pain, including migraines. When performed by trained physicians, it is safe and typically reduces headache frequency and intensity, as well as nausea and vomiting, lowering the need for pain medication.

Investigators are exploring three different ways to help manage migraine headaches using gentle stimulation techniques. These include laser acupuncture, electroacupuncture, and traditional acupuncture.

Investigators want to see which method works best for reducing migraine symptoms. Investigators will look at how participants feel after treatment and also check blood samples for signs of inflammation and certain substances linked to migraines, such as calcitonin gene-related peptide (CGRP) and markers of brain stress.

Investigators have a goal to find safe and effective options that can improve migraine care and help people feel better.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine Headache Migraine Headache, With or Without Aura Migraine in Adults Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

Investigators are conducting a study to compare three different types of acupuncture treatments. Each participant will be carefully evaluated to meet the requirements for participation. Before joining, each participant will have a conversation with investigators to explain the study and answer any questions.

Participants will be randomly placed into one of three groups:

Traditional Acupuncture - standard acupuncture treatment Electroacupuncture - standard acupuncture combined with gentle electrical stimulation.

Laser Acupuncture - standard acupuncture combined with acupuncture using a low-level laser instead of needles.

After the treatment, Investigators will check in with participants again after 1 and 3 months to see how they are feeling and whether the effects have lasted.Participation is voluntary, with no financial compensation, and care will not be affected by the decision to participate.

Outcomes will be assessed using questionnaires before treatment and for three months afterward, measuring migraine days, pain intensity, medication use, headache frequency, and satisfaction of participants. Blood samples will be collected at baseline, after treatment, and three months later to analyze migraine-related biomarkers. Results will be statistically evaluated. Investigators expect acupuncture to reduce headache severity and medication use.

So far, there has been no direct comparison of these three methods. Investigators want to find out:

Which method works best. How long the benefits last. Whether participants need repeat treatments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults diagnosed with migraine headaches according to the International Classification of Headache Disorders (ICHD).
  • Patients who are not currently receiving monoclonal antibodies targeting CGRP (Calcitonin Gene-Related Peptide)
  • Ability to provide informed consent and comply with study procedures. Exclusion Criteria
  • Use of CGRP monoclonal antibody therapy within the past 6 months.
  • Other significant neurological or systemic conditions that could interfere with study outcomes.
  • Pregnancy or breastfeeding.

Treatment and study plan

Standard acupuncture

Other

standard acupuncture on the scalp and distal acupuncture point that will not be stimulated with electro or laser device

electroacupuncture

Other

Electroacupuncture - distal acupuncture points will be stimulated will electronic device that is used for electroacupuncture

Laser Acupuncture

Other

Distal acupuncture points will be stimulated with laser needles

Primary outcomes

  1. NRS 3

    Time frame: Baseline and three months from last acupuncture stimulation

    Pain intensity three months after treatment measured with NRS (Numeric rate scale) from 0 (for = pain) to 10 (maximal pain)

Secondary outcomes

  1. HIT- 6

    Time frame: Baseline and three months from last acupuncture stimulation

    HIT-6 stands for Headache Impact Test - 6 items.Higher scores indicate a greater impact of migraine on the life of partcipants. The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) Score range 36-78 It is widely used for people with migraine or other headache disorders. The goal is to understand the impact of headaches on daily functioning, not just pain intensity.

  2. MIDAS

    Time frame: Baseline and three months from last acupuncture stimulation

    The MIDAS questionnaire stands for Migraine Disability Assessment. It is a tool used to measure how much migraines affect a person's daily life and productivity. Scores on the MIDAS are highly correlated with physician judgments about the severity of illness and need for treatment. The score of this instrument is as follows: little or no disability, 5 to 10; moderate disability, 1 to 20; and severe disability, more than 20.

  3. Biomarkers of brain injury and inflammatory response

    Time frame: Baseline, day of last acupuncture stimulation and three months from last acupuncture stimulation

    We will take blood samples for interleukin - 6, 8 and 10 (Il6, IL8, IL10), leptin, Nerve growth factor (NGF), S100 calcium-binding protein A8 (S100A8), Brain-derived neurotrophic factor (BDNF) and CGRP

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Acronym: ACUPMIGRAINE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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