The Effect of Static Magnetic Fields on Neuroinflammation in Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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)
- •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.
- •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)
研究组 & 干预措施
Patients with Migraine
This arm will undergo the 21-day at-home self-administered non-drug intervention
干预措施: Static magnetic helmet (Device)
研究者
Marco Loggia
Professor of Radiology and Anaesthesia
Massachusetts General Hospital