The Effect of Static Magnetic Fields on Neuroinflammation in Migraine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine in Adults
• Intervention / Treatment: Device: Static magnetic helmet

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco L Loggia, PhD; Phone Number: 617-643-7267; Email: marco.loggia@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • A.A. Martinos Center for Biomedical Imaging
      • Contact: Marco L Loggia, PhD; Phone Number: 617-643-7267; Email: marco.loggia@mgh.harvard.edu
      • Principal Investigator: Marco L Loggia, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Between 18 and 65 years of age.

2. 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

3. The frequency of migraine attacks must be at least 4 migraine-days per month.
4. The duration of the disease must be of at least one year.
5. Willingness to adhere to daily intervention sessions and complete study procedures.
6. Able to give written consent in English.

Exclusion Criteria:

1. Greater than 20 headache days per month.
2. 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.
3. 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).
4. 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.
5. 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).
6. Medication overuse, using ICHD-3 beta criteria framework for medication overuse.
7. Other chronic pain disorder whose intensity exceeds the intensity of pain during migraine headaches.
8. Moderate or high levels of opioid use (>60mg Morphine equivalents).
9. Participation in other concurrent therapeutic trials.
10. New pharmacotherapy started within 4 weeks of the screening visit or inconsistent pharmacotherapy for the duration of the study that could impact study.
11. 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.
12. 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.
13. 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)
14. 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.
15. 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).
16. Hypotension (defined as blood pressure <90/60mmHG) that would impact study participation.
17. History of COVID-19 infection within the past 3 months WITH neurological symptoms.
18. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Migraine; This arm will undergo the 21-day at-home self-administered non-drug intervention	Device: Static magnetic helmet; Participants will wear a static magnetic helmet for 20 minutes daily during a 21-day intervention period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional Brain [11C]PBR28 PET Signal	Regional PET signal quantified as the standardized uptake value ratio	From the pre-intervention scan to the post-intervention scan, approximately 21 days later

Collaborators and Investigators

• Sponsor: Marco Loggia

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MRI; PET/CT; Brain imaging; Non-drug self-administered at-home intervention
• Other Study ID Numbers: 2026P000716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No