MigraineACUPMIGRAINENCT07292506
The Impact of Acupuncture on Biomarkers of Brain Injury and Inflammatory Response in Migraine
A study testing Standard acupuncture, Electroacupuncture and Laser Acupuncture in people with Migraine and Migraine Headache, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Migraine Headache, Migraine Headache, With or Without Aura
- What is being tested?
- Standard acupuncture, Electroacupuncture and Laser Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Nov 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana
Ljubljana, 1000
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Standard acupuncture, Electroacupuncture, Laser Acupuncture
- Keywords
- electroacupuncture, migraine, acupuncture, biomarkers of brain injury, inflammatory response, laser acupuncture, traditional acupuncture
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard acupunctureOther
standard acupuncture on the scalp and distal acupuncture point that will not be stimulated with electro or laser device
ElectroacupunctureOther
Electroacupuncture - distal acupuncture points will be stimulated will electronic device that is used for electroacupuncture
Laser AcupunctureOther
Distal acupuncture points will be stimulated with laser needles
| Study group | Role | What they receive |
|---|---|---|
| Standard acupuncture | Active comparator | Traditional Acupuncture - standard acupuncture treatment on local scalp and distal points Receives: 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 Receives: 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 Receives: Other: Standard acupuncture; Other: Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS 3
Pain intensity three months after treatment measured with NRS (Numeric rate scale) from 0 (for = pain) to 10 (maximal pain)
Measured: Baseline and three months from last acupuncture stimulation
Secondary outcomes (3)
HIT- 6
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.
Measured: Baseline and three months from last acupuncture stimulation
MIDAS
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.
Measured: Baseline and three months from last acupuncture stimulation
Biomarkers of brain injury and inflammatory response
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
Measured: Baseline, day of last acupuncture stimulation and three months from last acupuncture stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start3 Nov 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Rupert, MD, Principal investigator, Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre LjubljanaJasmina Markovic Bozic, MD, Phd, Asist. Prof., Study chair, Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292506
- Sponsor's protocol ID
- 0120-319/2024-2711-6
- Acronym
- ACUPMIGRAINE
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32213509Liu 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.
PubMed 26700695Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.
PubMed 30681821
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acupuncture on Biomarkers of Brain Injury and Inflammatory Response in Migraine
- ClinicalTrials.gov ID
- NCT07292506
- Acronym / sponsor ID
- ACUPMIGRAINE / 0120-319/2024-2711-6
- Keywords
- electroacupuncture, migraine, acupuncture, biomarkers of brain injury, inflammatory response, laser acupuncture, traditional acupuncture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard acupuncture | Active comparator | Other: Standard acupunctureTraditional Acupuncture - standard acupuncture treatment on local scalp and distal points |
| Electroacupuncture | Active comparator | Other: Standard acupuncture, Other: ElectroacupunctureElectroacupuncture - standard acupuncture on local scalp points combined with gentle electrical stimulation of the needles placed on distal points |
| Laser Acupuncture | Active comparator | Other: Standard acupuncture, Other: Laser AcupunctureLaser Acupuncture - standard acupuncture on local scalp points combined with low-level laser instead of needles on distal acupuncture points |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard acupuncturestandard acupuncture on the scalp and distal acupuncture point that will not be stimulated with electro or laser device | Other | Electroacupuncture, Laser Acupuncture, Standard acupuncture |
| ElectroacupunctureElectroacupuncture - distal acupuncture points will be stimulated will electronic device that is used for electroacupuncture | Other | Electroacupuncture |
| Laser AcupunctureDistal acupuncture points will be stimulated with laser needles | Other | Laser Acupuncture |
Primary outcome
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)
3 secondary outcomes
HIT- 6
Time frame: Baseline and three months from last acupuncture stimulation
MIDAS
Time frame: Baseline and three months from last acupuncture stimulation
Biomarkers of brain injury and inflammatory response
Time frame: Baseline, day of last acupuncture stimulation and three months from last acupuncture stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Results publication: PubMed 32213509Xu 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.
- Results publication: PubMed 26700695Liu 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.
- Results publication: PubMed 30681821Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Rupert, MD principal investigator
Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana
Jasmina Markovic Bozic, MD, Phd, Asist. Prof. study chair
Clinical department of anaesthesiology and surgical intensive therapy University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard acupuncture, Electroacupuncture and Laser Acupuncture in people with Migraine and Migraine Headache, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS 3 (time frame: Baseline and three months from last acupuncture stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07292506, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.