The Effect of Static Magnetic Fields on Neuroinflammation in Migraine

Korábbi kezelés

• Medication overuse, using ICHD-3 beta criteria framework for medication overuse.
• Participation in other concurrent therapeutic trials.
• 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.
• 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)

Más betegség

• 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).
• Other chronic pain disorder whose intensity exceeds the intensity of pain during migraine headaches.
• 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).
• 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)

Egyéb

• Greater than 20 headache days per month.
• Moderate or high levels of opioid use (>60mg Morphine equivalents).
• New pharmacotherapy started within 4 weeks of the screening visit or inconsistent pharmacotherapy for the duration of the study that could impact study.
• Hypotension (defined as blood pressure <90/60mmHG) that would impact study participation.

• 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.