Using the ShiraTronics Migraine Therapy System for chronic migraines
A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
This study is testing a new device called the ShiraTronics Migraine Therapy System to see if it can help adults with chronic migraines who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | ShiraTronics Industry-sponsored |
| Locations | 4 sites (Broadmeadow, New South Wales and 3 other locations) |
| Trial ID | NCT05700318 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of the ShiraTronics Migraine Therapy System as a preventive treatment for patients suffering from refractory chronic migraines. Participants will be adults aged 22 and older who experience a high frequency of headache days and have not responded adequately to standard migraine therapies. The intervention involves the use of a neurostimulator designed to alleviate migraine symptoms. The study aims to gather preliminary data on the device's performance in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with a history of chronic migraines and inadequate response to other migraine treatments.
Not a fit: Patients with post-traumatic headaches, medication overuse headaches, or those who have previously undergone neurostimulation for migraines may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with chronic migraines who have not found relief from existing medications.
How similar studies have performed: While this approach is novel, similar neurostimulation techniques have shown promise in treating chronic migraines in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Broadmeadow, New South Wales and 3 other locations
- Genesis Research Services — Broadmeadow, New South Wales, Australia (Recruiting)
- Australian Medical Research — Hurstville, New South Wales, Australia (Recruiting)
- CerCare — Wayville, South Australia, Australia (Recruiting)
- Paincare Perth — Perth, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Fred Ecklund
- Email: fecklund@shiratronics.com
- Phone: 1-844-228-7330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.