Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-05-05
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neurostimulation
Neurostimulation will be delivered to target nerves.
neurostimulator
The ShiraTronics Migraine Therapy System
Interventions
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neurostimulator
The ShiraTronics Migraine Therapy System
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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ShiraTronics
INDUSTRY
Responsible Party
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Principal Investigators
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Scientific Advisory Board
Role: STUDY_DIRECTOR
ShiraTronics
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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STCM01
Identifier Type: -
Identifier Source: org_study_id
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