NCT05700318
Recruiting
Not Applicable
A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
ShiraTronics4 sites in 1 country40 target enrollmentMay 5, 2023
ConditionsChronic Migraine, Headache
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Migraine, Headache
- Sponsor
- ShiraTronics
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Monthly Headache Days
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants who are 22 years of age or older.
- •History of migraine ≥ 12 months.
- •Participants experiencing between 15 to 26 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation.
- •Inadequate response to, unwilling, or contraindicated to Onabotulinumtoxin A and CGRP monoclonal antibodies therapy.
- •Stable use of migraine medication.
Exclusion Criteria
- •Post-traumatic headache.
- •Medication overuse headache.
- •New daily persistent headache.
- •Report experiencing unremitting, continuous headaches with no relief.
- •Previously implanted neurostimulator to treat headache.
- •History of cervical radiofrequency ablation or had any other intervention/device for migraine.
Outcomes
Primary Outcomes
Monthly Headache Days
Time Frame: 12-weeks
Change in number of mean monthly headache days
Secondary Outcomes
- 50% reduction in mean Headache days(12-weeks)
- Migraine Disability Assessment Test(12-weeks)
- Monthly Migraine Days(12-weeks)
- Patient-identified Most Bothersome Symptom(12-weeks)
Study Sites (4)
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