Chronic MigraineNCT05769348
Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
A study testing HD-tDCS Active Protocol in people with Chronic Migraine, run by University of Michigan at 1 site in United States.
Trial summary
This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes/once per day for twenty days (M-F) can reduce migraine pain. Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a "sham" procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- HD-tDCS Active Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to 30 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 65 (inclusive)
- Patients must have Episodic migraines that started before the age of 50, and currently experience:
- Chronic migraine (ICHD-3-beta), headache occurring on 15 days/month for more than six months, which, on at least eight days/month, has the features of a migraine headache.
- Episodic migraine (low frequency), specifically those with headache occurring less than 8 days/month.
- Willing to limit the introduction of new treatments and medications during the study period.
Who cannot join
- Significantly greater pain in body sites other than the head
- Active, untreated major concurrent systemic illness other than migraine
- Medical conditions that can impair health status independent of migraine (including cardiopulmonary disorders, malignancy, uncontrolled endocrine or allergies)
- Systemic rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia);
- History or current evidence of a psychotic disorder (e.g., bipolar disorder, schizophrenia) or severe major depression, as evidenced by Beck Depression score of >30*
- History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)
Show all 13Show fewer
- Medication overuse headache (ICHD-3), regular intake for ≥10 days per month of ergotamine, triptans, combination analgesics, or any combination thereof OR ≥15 days per month of simple analgesics (acetaminophen, aspirin, NSAID), for more than 3 months
- Current use of opioid or dopaminergic drugs (or use within the last 3 months) or substance abuse (self-reported)
- Drug test positive for opioid or recreational drug (e.g., cannabis) at the time of the PET scan visits
- Allergic response to study radiotracers or chemically related drugs
- Excluded by MRI Center or PET Center safety screening checklist (as administered by study staff)
- Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)
- Prior use of tDCS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Jacqueline Dobson, 734-763-8469, ContactHOPE@umich.edu
About this study
This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes/once per day for twenty days (M-F) can reduce migraine pain. Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a "sham" procedure. Another 20 Episodic Migraine patients will be recruited for the observational aim of the study which does not include brain stimulation.
Read the detailed description
Clinical Trial:
This is a phase 2, single center, three-arm, double-masked, randomized investigation and modulation of the µ-opioid and D2/D3 mechanisms in chronic migraine (in vivo). We will enroll 60 patients with Chronic Migraine divided into 3 Lab/Home-Based groups: 20 for the active unilateral M11-2 HD-tDCS group, 20 for the active bilateral M11-2 HD-tDCS group, and 20 for the sham M11-2 HD-tDCS group. Patients will complete a screening visit, baseline visit with MRI and PET session, 20 days of HD-tDCS brain stimulation treatments, as well as follow-up visits with an MRI and PET session.
Observational Study Arm:
20 additional patients with low frequency EM (<8 attacks/month) patients (that did not undergo neuromodulation) will be recruited for the study. Historical data may be used in place of recruiting new participants. Data from these 20 EM volunteers will be compared to that of CM patients at baseline; however, they will not be part of the clinical trial.
- Conditions
- Chronic Migraine
- Being tested
- HD-tDCS Active Protocol, HD-tDCS Sham Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCS Active ProtocolDevice
non-invasive brain stimulation (active protocol)
HD-tDCS Sham ProtocolDevice
non-invasive brain stimulation (sham protocol)
| Study group | Role | What they receive |
|---|---|---|
| Active Unilateral Treatment | Active comparator | Chronic migraine patients will be randomized (Taves method) to receive UNILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks). Receives: Device: HD-tDCS Active Protocol |
| Active Bilateral Treatment | Active comparator | Chronic migraine patients will be randomized (Taves method) to receive BILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks). Receives: Device: HD-tDCS Active Protocol |
| Sham Treatment | Sham comparator | Chronic migraine patients will be randomized (Taves method) to receive SHAM high-definition transcranial direct current stimulation (HD-tDCS*) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 20 days (M-F for 4 weeks). Receives: Device: HD-tDCS Sham Protocol |
| No Treatment | No intervention | Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in moderate to severe headache days over 1 month follow-up
Headache Day: day with a headache that causes moderate or severe pain (at its peak, defined as NRS ≥ 4) that lasts at least 4 hours, OR day with a headache that is treated by an acute headache medication.
Measured: baseline to 1 month follow-up
Secondary outcomes (4)
Change from baseline in headache days over 1-month follow-up
Day with a headache that lasts at least 2 hours, OR day with a headache that is treated by an acute headache medication.
Measured: baseline to 1 month follow-up
Responder rate over 1-month follow-up
50% percent reduction (from baseline to post tDCS) in the number of moderate or severe headache days.
Measured: baseline to 1 month follow-up
Changes from baseline in medication use days over 1-month follow-up
- Medication use is defined as a day when the patient reports intake of medication for the acute treatment of headache
Measured: baseline to 1 month follow-up
Intensity of headache over 1-month follow-up
Each headache day is rated in terms of maximum intensity on a 0 to 10 NRS scale and averaged headache intensity will be used.
Measured: baseline to 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start26 Jan 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre DaSilva, DDS, DMedSc, University of Michigan
- Investigators
- Alexandre DaSilva, DDS, DMedSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769348
- Sponsor's protocol ID
- HUM00213295
- Other IDs
- R01NS094413
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
- ClinicalTrials.gov ID
- NCT05769348
- Acronym / sponsor ID
- HUM00213295
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Mar 2023 (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.
This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes/once per day for twenty days (M-F) can reduce migraine pain. Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a "sham" procedure. Another 20 Episodic Migraine patients will be recruited for the observational aim of the study which does not include brain stimulation.
Detailed description
Clinical Trial:
This is a phase 2, single center, three-arm, double-masked, randomized investigation and modulation of the µ-opioid and D2/D3 mechanisms in chronic migraine (in vivo). We will enroll 60 patients with Chronic Migraine divided into 3 Lab/Home-Based groups: 20 for the active unilateral M11-2 HD-tDCS group, 20 for the active bilateral M11-2 HD-tDCS group, and 20 for the sham M11-2 HD-tDCS group. Patients will complete a screening visit, baseline visit with MRI and PET session, 20 days of HD-tDCS brain stimulation treatments, as well as follow-up visits with an MRI and PET session.
Observational Study Arm:
20 additional patients with low frequency EM (<8 attacks/month) patients (that did not undergo neuromodulation) will be recruited for the study. Historical data may be used in place of recruiting new participants. Data from these 20 EM volunteers will be compared to that of CM patients at baseline; however, they will not be part of the clinical trial.
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 |
|---|---|---|
| Active Unilateral Treatment | Active comparator | Device: HD-tDCS Active ProtocolChronic migraine patients will be randomized (Taves method) to receive UNILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks). |
| Active Bilateral Treatment | Active comparator | Device: HD-tDCS Active ProtocolChronic migraine patients will be randomized (Taves method) to receive BILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks). |
| Sham Treatment | Sham comparator | Device: HD-tDCS Sham ProtocolChronic migraine patients will be randomized (Taves method) to receive SHAM high-definition transcranial direct current stimulation (HD-tDCS*) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 20 days (M-F for 4 weeks). |
| No Treatment | No intervention | –Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 18 to 65 (inclusive)
- Patients must have Episodic migraines that started before the age of 50, and currently experience:
- Willing to limit the introduction of new treatments and medications during the study period.
Key exclusion criteria (13 listed)
- Significantly greater pain in body sites other than the head
- Active, untreated major concurrent systemic illness other than migraine
- History or current evidence of a psychotic disorder (e.g., bipolar disorder, schizophrenia) or severe major depression, as evidenced by Beck Depression score of >30*
- History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)
- Medication overuse headache (ICHD-3), regular intake for ≥10 days per month of ergotamine, triptans, combination analgesics, or any combination thereof OR ≥15 days per month of simple analgesics (acetaminophen, aspirin, NSAID), for more than 3 months
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 |
|---|---|---|
| HD-tDCS Active Protocolnon-invasive brain stimulation (active protocol) | Device | Active Bilateral Treatment, Active Unilateral Treatment |
| HD-tDCS Sham Protocolnon-invasive brain stimulation (sham protocol) | Device | Sham Treatment |
Primary outcome
Change from baseline in moderate to severe headache days over 1 month follow-up
Time frame: baseline to 1 month follow-up
Headache Day: day with a headache that causes moderate or severe pain (at its peak, defined as NRS ≥ 4) that lasts at least 4 hours, OR day with a headache that is treated by an acute headache medication.
4 secondary outcomes
Change from baseline in headache days over 1-month follow-up
Time frame: baseline to 1 month follow-up
Responder rate over 1-month follow-up
Time frame: baseline to 1 month follow-up
Changes from baseline in medication use days over 1-month follow-up
Time frame: baseline to 1 month follow-up
Intensity of headache over 1-month follow-up
Time frame: baseline to 1 month follow-up
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 25 Feb 2026.
- 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.
Alexandre DaSilva, DDS, DMedSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tDCS Active Protocol in people with Chronic Migraine, run by University of Michigan at 1 site in United States.
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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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 United States. 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?
Contact Jacqueline Dobson, BA ((734)763-8469, contactHOPE@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in moderate to severe headache days over 1 month follow-up (time frame: baseline to 1 month follow-up). 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 25 Feb 2026.