Migraine in AdultsNCT07584382
The Effect of Static Magnetic Fields on Neuroinflammation in Migraine
A study testing Static magnetic helmet in people with Migraine in Adults, run by Marco Loggia at 1 site in United States.
Trial summary
We are conducting this research in individuals with migraines to find out if a daily magnet helmet application could alter migraine-related brain inflammation. Outcomes will be assessed through examining any changes in Translocator Protein (TSPO) binding on Positron Emission Tomography-Computed Tomography (PET-CT)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine in Adults
- What is being tested?
- Static magnetic helmet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 1 Sep 2027
- 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
- Between 18 and 65 years of age.
- Migraine diagnosis must come from a neurologist or other qualified MD, and the diagnosis must meet International Classification of Headache Diagnosis, Version 3 (ICHD-3) beta criteria for migraine according to either of the categories:
- ICHD-3 beta 1.1: Migraine without aura ICHD-3 beta 1.2: Migraine with aura
- The frequency of migraine attacks must be at least 4 migraine-days per month.
- The duration of the disease must be of at least one year.
- Willingness to adhere to daily intervention sessions and complete study procedures.
- Able to give written consent in English.
Who cannot join
- Greater than 20 headache days per month.
- Major systemic illness (e.g., brain tumor, severe hypertension) or unstable medical and/or psychiatric condition (e.g., suicide risk, requiring immediate treatment) that could compromise protocol adherence.
- Evidence of relevant co-morbidity, systemic or not, with potential to substantially interfere with the phenotype of the conditions studied in the present protocol (e.g., history of Type I or Type II diabetes mellitus unless well managed).
- A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion), which may confound the results of the study.
- Symptoms that could impact protocol adherence or be disruptive to study participation (e.g., Tourette's, schizophrenia with current psychosis, bipolar 1 disorder, severe OCD, current severe episode of major depression, dissociative disorder, severe PTSD, severe personality disorder, traumatic brain injury, severe agoraphobia).
- Medication overuse, using ICHD-3 beta criteria framework for medication overuse.
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- Other chronic pain disorder whose intensity exceeds the intensity of pain during migraine headaches.
- Moderate or high levels of opioid use (>60mg Morphine equivalents).
- Participation in other concurrent therapeutic trials.
- New pharmacotherapy started within 4 weeks of the screening visit or inconsistent pharmacotherapy for the duration of the study that could impact study.
- Subjects who are prescribed preventative CGRP medications that include CGRP antibodies and oral CGRP receptor antagonists and have been taking them for <3 months before screening.
- Meets criteria for active, non-remitted, DSM-V Moderate or Severe Substance Use Disorder, or demonstrates regular substance use (assessed by self-report and/or urine screening) in a manner which would impact the protocol.
- General magnet helmet, MRI, and PET-CT safety exclusion criteria (e.g., implanted pacemakers or defibrillators, deep brain stimulators, cochlear implants, programmable shunts, ferromagnetic cranial implants, routine use of benzodiazepines or any use in the 2 weeks prior to the scan(s), except clonazepam, lorazepam, and alprazolam, which show very low binding affinity to TSPO, low-affinity binder phenotype from genotyping the TSPO rs6971 polymorphism, pregnancy or breastfeeding, electrical or ferromagnetic implants, claustrophobia, >300 lbs, use of certain antibiotics such as minocycline, inability to lie comfortably on a bed inside the scanner for at least 90 minutes)
- Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol. This includes unreliable or inconsistent completion of daily check-ins during the intervention period.
- Diagnosis of significant cardiovascular or cerebrovascular disease (e.g., congestive heart failure, stroke, cardiac conduction disorders (e.g., bundle branch block, heart block, long Q-T syndrome), history of asystole or non-sustained ventricular tachycardia).
- Hypotension (defined as blood pressure <90/60mmHG) that would impact study participation.
- History of COVID-19 infection within the past 3 months WITH neurological symptoms.
- Contraindications to the placement of an arterial line (e.g., abnormal result on the modified Allen's test on both hands, severe Raynaud's syndrome or peripheral neuropathy, bleeding disorder, use of anticoagulants such as Coumadin, Plavix or Lovenox)
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
A.A. Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, 02129
Marco L Loggia, PhD, 617-643-7267, marco.loggia@mgh.harvard.edu
Marco L Loggia, PhD
About this study
We are conducting this research in individuals with migraines to find out if a daily magnet helmet application could alter migraine-related brain inflammation. Outcomes will be assessed through examining any changes in Translocator Protein (TSPO) binding on Positron Emission Tomography-Computed Tomography (PET-CT) imaging both before and after the magnet helmet intervention period. Additionally, patient-reported migraine symptoms will be measured using validated questionnaires administered during the four-week pre- and post- intervention monitoring periods.
Read the detailed description
This pilot study is designed to evaluate the preliminary biological signals associated with a non-drug, at-home, self-administered intervention in individuals with migraine. This study will last approximately 11 weeks and involve three in-person visits to the Massachusetts General Hospital Charlestown Navy Yard campus. The first visit will involve screening tests to determine eligibility. The second and third visits will both be imaging visits, where participants would undergo PET-CT scans, as well as additional Magnetic Resonance Imaging (MRI) scan. These scan visits will be performed before and after a ~3-week (21 day) intervention period where participants will be instructed to wear the magnet helmet for 20 minutes daily. Throughout the study, participants will complete various questionnaires regarding their migraines, including a daily migraine symptom survey. This study is not powered to determine clinical efficacy; rather, its primary purpose is to obtain preliminary data to inform the design of future, larger-scale controlled trials.
- Conditions
- Migraine in Adults
- Being tested
- Static magnetic helmet
- Keywords
- Brain imaging, Non-drug self-administered at-home intervention, PET/CT, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static magnetic helmetDevice
Participants will wear a static magnetic helmet for 20 minutes daily during a 21-day intervention period
| Study group | Role | What they receive |
|---|---|---|
| Patients with Migraine | Experimental | This arm will undergo the 21-day at-home self-administered non-drug intervention Receives: Device: Static magnetic helmet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Brain [11C]PBR28 PET Signal
Regional PET signal quantified as the standardized uptake value ratio
Measured: From the pre-intervention scan to the post-intervention scan, approximately 21 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start30 Oct 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in AdultsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Loggia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Loggia, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584382
- Sponsor's protocol ID
- 2026P000716
- Status last verified
- Aug 2026
- First submitted
- 7 May 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Static Magnetic Fields on Neuroinflammation in Migraine
- ClinicalTrials.gov ID
- NCT07584382
- Acronym / sponsor ID
- 2026P000716
- Conditions
- Migraine in Adults
- Keywords
- Brain imaging, Non-drug self-administered at-home intervention, PET/CT, MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Marco LoggiaUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 13 May 2026 (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.
We are conducting this research in individuals with migraines to find out if a daily magnet helmet application could alter migraine-related brain inflammation. Outcomes will be assessed through examining any changes in Translocator Protein (TSPO) binding on Positron Emission Tomography-Computed Tomography (PET-CT) imaging both before and after the magnet helmet intervention period. Additionally, patient-reported migraine symptoms will be measured using validated questionnaires administered during the four-week pre- and post- intervention monitoring periods.
Detailed description
This pilot study is designed to evaluate the preliminary biological signals associated with a non-drug, at-home, self-administered intervention in individuals with migraine. This study will last approximately 11 weeks and involve three in-person visits to the Massachusetts General Hospital Charlestown Navy Yard campus. The first visit will involve screening tests to determine eligibility. The second and third visits will both be imaging visits, where participants would undergo PET-CT scans, as well as additional Magnetic Resonance Imaging (MRI) scan. These scan visits will be performed before and after a ~3-week (21 day) intervention period where participants will be instructed to wear the magnet helmet for 20 minutes daily. Throughout the study, participants will complete various questionnaires regarding their migraines, including a daily migraine symptom survey. This study is not powered to determine clinical efficacy; rather, its primary purpose is to obtain preliminary data to inform the design of future, larger-scale controlled trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Migraine | Experimental | Device: Static magnetic helmetThis arm will undergo the 21-day at-home self-administered non-drug intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between 18 and 65 years of age.
- Migraine diagnosis must come from a neurologist or other qualified MD, and the diagnosis must meet International Classification of Headache Diagnosis, Version 3 (ICHD-3) beta criteria for migraine according to either of the categories:
- ICHD-3 beta 1.1: Migraine without aura ICHD-3 beta 1.2: Migraine with aura
- The frequency of migraine attacks must be at least 4 migraine-days per month.
- The duration of the disease must be of at least one year.
Key exclusion criteria (18 listed)
- Greater than 20 headache days per month.
- Major systemic illness (e.g., brain tumor, severe hypertension) or unstable medical and/or psychiatric condition (e.g., suicide risk, requiring immediate treatment) that could compromise protocol adherence.
- Evidence of relevant co-morbidity, systemic or not, with potential to substantially interfere with the phenotype of the conditions studied in the present protocol (e.g., history of Type I or Type II diabetes mellitus unless well managed).
- A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion), which may confound the results of the study.
- Symptoms that could impact protocol adherence or be disruptive to study participation (e.g., Tourette's, schizophrenia with current psychosis, bipolar 1 disorder, severe OCD, current severe episode of major depression, dissociative disorder, severe PTSD, severe personality disorder, traumatic brain injury, severe agoraphobia).
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 |
|---|---|---|
| Static magnetic helmetParticipants will wear a static magnetic helmet for 20 minutes daily during a 21-day intervention period | Device | Patients with Migraine |
Primary outcome
Regional Brain [11C]PBR28 PET Signal
Time frame: From the pre-intervention scan to the post-intervention scan, approximately 21 days later
Regional PET signal quantified as the standardized uptake value ratio
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 31 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static magnetic helmet in people with Migraine in Adults, run by Marco Loggia 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 7 inclusion and 18 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: opening soon, as of the sponsor's last update on 31 Aug 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. 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 Marco L Loggia, PhD (617-643-7267, marco.loggia@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Brain [11C]PBR28 PET Signal (time frame: From the pre-intervention scan to the post-intervention scan, approximately 21 days later). 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 31 Aug 2026.