The Effect of Static Magnetic Fields on Neuroinflammation in Migraine

NCT ID
NCT07584382
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Marco Loggia
Conditions
Migraine in Adults

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 10 participants (Estimated).

What is being studied

  • Device: Static magnetic helmet

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Massachusetts, United States: 1

Sample of listed locations

  • A.A. Martinos Center for Biomedical Imaging — Charlestown, Massachusetts, 02129, United States — Site recruitment status not specified in the registry data

Study details

Start date
October 30, 2026
Primary completion date
July 1, 2027
Completion date
September 1, 2027
First posted
May 13, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07584382
Registry last updated
August 31, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07584382 on ClinicalTrials.gov

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