Chronic Migraine, HeadacheRELIEV-CMNCT05700318
Study Using the ShiraTronics Migraine Therapy System
A study testing neurostimulator in people with Chronic Migraine, Headache, run by ShiraTronics at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Migraine, Headache
- What is being tested?
- neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesAustralia
- Study dates
- 5 May 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites, 4 recruiting
- Recruiting
Genesis Research Services
Broadmeadow, New South Wales
+61 2 4985 1860
- Recruiting
Australian Medical Research
Hurstville, New South Wales
+61 (02) 9570 5550
- Recruiting
Paincare Perth
Perth, Western Australia
+61 8 9284 6005
- Recruiting
CerCare
Wayville, South Australia
+61 410 567 855
About this study
Official title: A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
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.
- Conditions
- Chronic Migraine, Headache
- Being tested
- neurostimulator
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurostimulatorDevice
The ShiraTronics Migraine Therapy System
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulation | Experimental | Neurostimulation will be delivered to target nerves. Receives: Device: neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Headache Days
Change in number of mean monthly headache days
Measured: 12-weeks
Secondary outcomes (4)
50% reduction in mean Headache days
Proportion of subjects with 50% reduction in mean monthly headache days
Measured: 12-weeks
Monthly Migraine Days
Change in mean monthly migraine days
Measured: 12-weeks
Migraine Disability Assessment Test
Change in disability score
Measured: 12-weeks
Patient-identified Most Bothersome Symptom
Change in most bothersome symptom
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start5 May 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShiraTronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scientific Advisory Board, Study director, ShiraTronics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700318
- Sponsor's protocol ID
- STCM01
- Acronym
- RELIEV-CM
- Status last verified
- Jul 2024
- First submitted
- 17 Jan 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
- ClinicalTrials.gov ID
- NCT05700318
- Acronym / sponsor ID
- RELIEV-CM / STCM01
- Conditions
- Chronic Migraine, Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ShiraTronicsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation | Experimental | Device: neurostimulatorNeurostimulation will be delivered to target nerves. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Post-traumatic headache.
- Medication overuse headache.
- New daily persistent headache.
- Report experiencing unremitting, continuous headaches with no relief.
- Previously implanted neurostimulator to treat headache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurostimulatorThe ShiraTronics Migraine Therapy System | Device | Neurostimulation |
Primary outcome
Monthly Headache Days
Time frame: 12-weeks
Change in number of mean monthly headache days
4 secondary outcomes
50% reduction in mean Headache days
Time frame: 12-weeks
Monthly Migraine Days
Time frame: 12-weeks
Migraine Disability Assessment Test
Time frame: 12-weeks
Patient-identified Most Bothersome Symptom
Time frame: 12-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scientific Advisory Board study director
ShiraTronics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurostimulator in people with Chronic Migraine, Headache, run by ShiraTronics at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fred Ecklund (1-844-228-7330, fecklund@shiratronics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Headache Days (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.