Study Using the ShiraTronics Migraine Therapy System
ConditionChronic Migraine, Headache
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorShiraTronics
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Post-traumatic headache.
Medication overuse headache.
New daily persistent headache.
Report experiencing unremitting, continuous headaches with no relief.
Trial design
Treatments tested in this trial
- neurostimulator
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
4Genesis Research Services BroadmeadowNew South Wales, Australia
Australian Medical Research HurstvilleNew South Wales, Australia
CerCare WayvilleSouth Australia, Australia
Paincare Perth PerthWestern Australia, Australia
Sponsors and collaborators
ShiraTronics
Lead sponsor
Source ClinicalTrials.gov