Study Using the ShiraTronics Migraine Therapy System
RELIEV-CM
A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
1 other identifier
interventional
40
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
May 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJuly 16, 2024
July 1, 2024
1.8 years
January 17, 2023
July 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Monthly Headache Days
Change in number of mean monthly headache days
12-weeks
Secondary Outcomes (4)
50% reduction in mean Headache days
12-weeks
Monthly Migraine Days
12-weeks
Migraine Disability Assessment Test
12-weeks
Patient-identified Most Bothersome Symptom
12-weeks
Study Arms (1)
Neurostimulation
EXPERIMENTALNeurostimulation will be delivered to target nerves.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ShiraTronicslead
Study Sites (4)
Genesis Research Services
Broadmeadow, New South Wales, Australia
Australian Medical Research
Hurstville, New South Wales, Australia
CerCare
Wayville, South Australia, Australia
Paincare Perth
Perth, Western Australia, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scientific Advisory Board
ShiraTronics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2023
First Posted
January 26, 2023
Study Start
May 5, 2023
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
July 16, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share