Chronic Migraine, Headache
Conditions
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.
Interventions
DEVICEneurostimulator
The ShiraTronics Migraine Therapy System
Sponsors
ShiraTronics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monthly Headache Days | 12-weeks | Change in number of mean monthly headache days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 50% reduction in mean Headache days | 12-weeks | Proportion of subjects with 50% reduction in mean monthly headache days |
| Monthly Migraine Days | 12-weeks | Change in mean monthly migraine days |
| Migraine Disability Assessment Test | 12-weeks | Change in disability score |
| Patient-identified Most Bothersome Symptom | 12-weeks | Change in most bothersome symptom |
Countries
Australia
Contacts
Primary ContactFred Ecklund
Outcome results
None listed