The Effect of Static Magnetic Fields on Neuroinflammation in Migraine

NCT07584382 | Not Yet Recruiting

• 1 other identifier: 2026P000716
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Migraine in Adults

Keywords

Brain imaging; Non-drug self-administered at-home intervention; PET/CT; MRI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with Migraine

EXPERIMENTAL

This arm will undergo the 21-day at-home self-administered non-drug intervention

Device: Static magnetic helmet

Interventions

Static magnetic helmet DEVICE

Participants will wear a static magnetic helmet for 20 minutes daily during a 21-day intervention period

Patients with Migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Marco Loggia: lead

Study Sites (1)

A.A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

Central Study Contacts

Marco L Loggia, PhD

CONTACT

617-643-7267; marco.loggia@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology and Anaesthesia

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)