Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Manhattan Beach Orthodontics
• Treatments: Erenumab

Criteria

Inclusion Criteria:

• Those eligible to participate must be between the ages of 18 to 55 years.

• The individual must experience at least 2 migraines per week.

• They must be capable of visiting the medical facility in Manhattan Beach, California where the in-person screening and final evaluation will be conducted (following COVID-19 public health guidelines).

• They must be able to communicate with the study team via any teleconferencing service such as Zoom, Google Hangouts, or FaceTime.

Exclusion Criteria:

• Patients must not have any intracranial pathology, neurological or psychological conditions, epilepsy, cancer, any history of chemotherapy, hospitalized for depression, psychiatric conditions, seizures, or tumors.

• Patients cannot have taken Botox® for migraine treatments.

• Patients cannot have had a history of head or neck surgery.

• Patients cannot be taking: propranolol, amitriptyline, flunarizine, topiramate, combination, galcanezumab-gnlm, fremanezumab-vfrm, or erenumab-aooe.

• Patients must not be deemed a vulnerable subject (including but not limited to:

children, prisoners, pregnant women, mentally disabled persons).