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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
neurostimulator
DeviceThe ShiraTronics Migraine Therapy System
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: NeurostimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Monthly Headache Days
Change in number of mean monthly headache days
Time frame
12-weeksSecondary outcomes
1
50% reduction in mean Headache days
Proportion of subjects with 50% reduction in mean monthly headache days
Time frame
12-weeks2
Monthly Migraine Days
Change in mean monthly migraine days
Time frame
12-weeks3
Migraine Disability Assessment Test
Change in disability score
Time frame
12-weeks4
Patient-identified Most Bothersome Symptom
Change in most bothersome symptom
Time frame
12-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov