Migraine in Adults
Conditions
Keywords
Brain imaging, Non-drug self-administered at-home intervention, PET/CT, MRI
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.
Detailed description
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.
Interventions
DEVICEStatic magnetic helmet
Participants will wear a static magnetic helmet for 20 minutes daily during a 21-day intervention period
Sponsors
Marco Loggia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional Brain [11C]PBR28 PET Signal | From the pre-intervention scan to the post-intervention scan, approximately 21 days later | Regional PET signal quantified as the standardized uptake value ratio |
Countries
United States
Contacts
CONTACTMarco L Loggia, PhD
Outcome results
None listed