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The Effect of Static Magnetic Fields on Neuroinflammation in Migraine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans, Questionnaires, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Throughout the study, participants will complete various questionnaires regarding their migraines, including a daily migraine symptom survey."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether wearing a magnet helmet each day can change brain inflammation linked to migraines. It is for adults ages 18 to 65 who have had migraines for at least one year. Researchers will use brain scans and surveys to track changes in inflammation and migraine symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 65 years old.
  • A qualified doctor has diagnosed migraine using the required guidelines, with or without aura (warning signs such as changes in vision).
  • You have migraines on at least 4 days each month.
  • You have had migraines for at least one year.
  • You are willing to complete daily helmet sessions and all study steps.
  • You can give written consent in English.

Who can't join

  • You have headaches on more than 20 days a month, overuse headache medicine, have another long-term pain condition that hurts more than your migraines, or use opioids above the study’s limit.
  • You have a serious or unstable illness, poorly controlled diabetes, a brain or nerve disease or injury, or mental health symptoms that could affect study results or participation. COVID-19 with brain or nerve symptoms within the past 3 months also excludes you.
  • You have significant heart or blood vessel disease, or blood pressure below 90/60 that would affect participation.
  • You are in another treatment trial, started a new medicine within 4 weeks before screening, or use medicines inconsistently in a way that could affect the study. You have taken preventive CGRP migraine medicines for less than 3 months.
  • You have an active moderate or severe substance use disorder, or regularly use substances in a way that could affect participation.
  • Helmet or scan safety rules exclude you. Examples include pregnancy or breastfeeding, certain metal or electronic implants, fear of enclosed spaces, weight over 300 pounds, or inability to lie in the scanner for 90 minutes. Certain medicines and a genetic test result showing low binding to the scan marker also exclude you.
  • You cannot safely have a small tube placed in an artery. Reasons may include poor blood flow in the hands, certain nerve problems, a bleeding disorder, or use of certain blood-thinning medicines.
  • The study team believes another condition or situation would keep you from completing the study, including unreliable daily check-ins.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

MA