The Effect of Static Magnetic Fields on Neuroinflammation in Migraine
ConditionMigraine in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarco Loggia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between 18 and 65 years of age.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Static magnetic helmet
DeviceParticipants will wear a static magnetic helmet for 20 minutes daily during a 21-day intervention period
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Patients with MigraineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Regional Brain [11C]PBR28 PET Signal
Regional PET signal quantified as the standardized uptake value ratio
Time frame
From the pre-intervention scan to the post-intervention scan, approximately 21 days laterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marco Loggia
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: