MigraineNCT06834022
Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation
A study testing Transcranial direct current stimulation and Acupuncture in people with Migraine, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Transcranial direct current stimulation and Acupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSlovenia
- Study dates
- 4 Apr 2023to 1 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4 migraine days per month
- no acupuncture in the past
- understanding of study design and ability to give informed consent
Who cannot join
- severe psychiatric disorders
- pacemaker
- status post brain surgery with open skull
- brain stimulators
- metal implants
- biologic drugs
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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.
- Conditions
- Migraine
- Being tested
- Transcranial direct current stimulation, Acupuncture
- Keywords
- tDCS, acupuncture, CGRP, inflammatory biomarkers
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
tDCS will be used according to instructions for use in migraine headache (supraorbital and M1 stimulation), 1 mA, 20 min, 10 sessions
AcupunctureProcedure or surgery
Acupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions
| Study group | Role | What they receive |
|---|---|---|
| Sham Acupuncture | Placebo comparator | Patients receive sham acupuncture (skin remains intact, away from standard acupuncture points) Receives: Procedure: Acupuncture |
| Verus Acupuncture | Active comparator | Patients receive acupuncture treatment over semistandardized acupuncture points for migraine headache. Receives: Procedure: Acupuncture |
| Sham tDCS | Placebo comparator | Device will provide only placebo stimulation (study mode) Receives: Device: Transcranial direct current stimulation |
| verus tDCS | Active comparator | Device will stimulate with direct current (study mode) Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with migraine headache per month
Evaluation of migraine days before study, at 1 nad 3 months after comleted therapy.
Measured: 4 months
Secondary outcomes (2)
Severity of migraine headache
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
Measured: 4 months
Change of inflammatory parameters
Measurements of laboratory levels of IL-6, IL-8, IL-10, leptin before treatment and at 1 and 3 months after therapy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start4 Apr 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alenka Spindler-Vesel, University Medical Centre Ljubljana
- Investigators
- Manja Mlakar, MD, Principal investigator, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834022
- Sponsor's protocol ID
- 0120-421/2022/3
- Status last verified
- Feb 2025
- First submitted
- 11 May 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT06834022
- Acronym / sponsor ID
- 0120-421/2022/3
- Conditions
- Migraine
- Keywords
- tDCS, acupuncture, CGRP, inflammatory biomarkers
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham Acupuncture | Placebo comparator | Procedure: AcupuncturePatients receive sham acupuncture (skin remains intact, away from standard acupuncture points) |
| Verus Acupuncture | Active comparator | Procedure: AcupuncturePatients receive acupuncture treatment over semistandardized acupuncture points for migraine headache. |
| Sham tDCS | Placebo comparator | Device: Transcranial direct current stimulationDevice will provide only placebo stimulation (study mode) |
| verus tDCS | Active comparator | Device: Transcranial direct current stimulationDevice will stimulate with direct current (study mode) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 4 migraine days per month
- no acupuncture in the past
- understanding of study design and ability to give informed consent
Key exclusion criteria (7 listed)
- severe psychiatric disorders
- pacemaker
- status post brain surgery with open skull
- brain stimulators
- metal implants
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 |
|---|---|---|
| Transcranial direct current stimulationtDCS will be used according to instructions for use in migraine headache (supraorbital and M1 stimulation), 1 mA, 20 min, 10 sessions | Device | Sham tDCS, verus tDCS |
| AcupunctureAcupuncture will be semistandardized, (every patient is stimulated over Li4, St36, Li3 + patient specific acu-points), 10 sessions | Procedure or surgery | Sham Acupuncture, Verus Acupuncture |
Primary outcome
Number of days with migraine headache per month
Time frame: 4 months
Evaluation of migraine days before study, at 1 nad 3 months after comleted therapy.
2 secondary outcomes
Severity of migraine headache
Time frame: 4 months
Change of inflammatory parameters
Time frame: 4 months
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 19 Feb 2025.
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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.
Manja Mlakar, MD principal investigator
University of 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 Transcranial direct current stimulation and Acupuncture in people with Migraine, 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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 19 Feb 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. Some participants in this study may receive a placebo. 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?
Number of days with migraine headache per month (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2025.