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

NCT07292506 | Active Not Recruiting

• 1 other identifier: 0120-319/2024-2711-6
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine; Migraine Headache; Migraine Headache, With or Without Aura; Migraine in Adults

Keywords

electroacupuncture; migraine; acupuncture; biomarkers of brain injury; inflammatory response; laser acupuncture; traditional acupuncture

Outcome Measures

Primary Outcomes (1)

• NRS 3

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

  Baseline and three months from last acupuncture stimulation

Secondary Outcomes (3)

• HIT- 6

  Baseline and three months from last acupuncture stimulation

• MIDAS

  Baseline and three months from last acupuncture stimulation

• Biomarkers of brain injury and inflammatory response

  Baseline, day of last acupuncture stimulation and three months from last acupuncture stimulation

Study Arms (3)

Standard acupuncture

ACTIVE COMPARATOR

Traditional Acupuncture - standard acupuncture treatment on local scalp and distal points

Other: Standard acupuncture

Electroacupuncture

ACTIVE COMPARATOR

Electroacupuncture - standard acupuncture on local scalp points combined with gentle electrical stimulation of the needles placed on distal points

Other: Standard acupuncture; Other: Electroacupuncture

Laser Acupuncture

ACTIVE COMPARATOR

Laser Acupuncture - standard acupuncture on local scalp points combined with low-level laser instead of needles on distal acupuncture points

Other: Standard acupuncture; Other: Laser Acupuncture

Interventions

Standard acupuncture OTHER

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

Electroacupuncture; Laser Acupuncture; Standard acupuncture

Electroacupuncture OTHER

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

Electroacupuncture

Laser Acupuncture OTHER

Distal acupuncture points will be stimulated with laser needles

Laser Acupuncture

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

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

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• Xu S, Yu L, Luo X, Wang M, Chen G, Zhang Q, Liu W, Zhou Z, Song J, Jing H, Huang G, Liang F, Wang H, Wang W. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial. BMJ. 2020 Mar 25;368:m697. doi: 10.1136/bmj.m697.

  PMID: 32213509 RESULT

• Liu Y, Yu S. Recent Approaches and Development of Acupuncture on Chronic Daily Headache. Curr Pain Headache Rep. 2016 Jan;20(1):4. doi: 10.1007/s11916-015-0535-7.

  PMID: 26700695 RESULT

• Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.

  PMID: 30681821 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Lea Rupert, MD

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

  PRINCIPAL INVESTIGATOR

• Jasmina Markovic Bozic, MD, Phd, Asist. Prof.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly placed into one of three groups: Traditional Acupuncture - standard acupuncture treatment on local scalp and distal points Electroacupuncture - standard acupuncture on local scalp points combined with gentle electrical stimulation of the needles placed on distal points Laser Acupuncture - standard acupuncture on local scalp points combined with low-level laser instead of needles on distal acupuncture points

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 18, 2025
• Study Start: November 3, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)