Study Using the ShiraTronics Migraine Therapy System

A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine

The purpose of this pilot study is to assess the preliminary safety and efficacy of the ShiraTronics Migraine Therapy System in prophylactic treatment of patients with refractory chronic migraine.

Inclusion Criteria:

1. Participants who are 22 years of age or older.
2. History of migraine ≥ 12 months.
3. Participants experiencing between 15 to 26 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation.
4. Inadequate response to, unwilling, or contraindicated to Onabotulinumtoxin A and CGRP monoclonal antibodies therapy.
5. Stable use of migraine medication.

Exclusion Criteria:

1. Post-traumatic headache.
2. Medication overuse headache.
3. New daily persistent headache.
4. Report experiencing unremitting, continuous headaches with no relief.
5. Previously implanted neurostimulator to treat headache.
6. History of cervical radiofrequency ablation or had any other intervention/device for migraine.