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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05700318
Registration number
NCT05700318
Ethics application status
Date submitted
17/01/2023
Date registered
26/01/2023
Date last updated
16/07/2024
Titles & IDs
Public title
Study Using the ShiraTronics Migraine Therapy System
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Scientific title
A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
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Secondary ID [1]
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STCM01
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Universal Trial Number (UTN)
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Trial acronym
RELIEV-CM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Migraine, Headache
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Condition category
Condition code
Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - neurostimulator
Experimental: Neurostimulation - Neurostimulation will be delivered to target nerves.
Treatment: Devices: neurostimulator
The ShiraTronics Migraine Therapy System
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Monthly Headache Days
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Assessment method [1]
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Change in number of mean monthly headache days
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Timepoint [1]
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12-weeks
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Secondary outcome [1]
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50% reduction in mean Headache days
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Assessment method [1]
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Proportion of subjects with 50% reduction in mean monthly headache days
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Timepoint [1]
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12-weeks
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Secondary outcome [2]
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Monthly Migraine Days
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Assessment method [2]
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Change in mean monthly migraine days
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Timepoint [2]
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12-weeks
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Secondary outcome [3]
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Migraine Disability Assessment Test
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Assessment method [3]
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Change in disability score
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Timepoint [3]
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12-weeks
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Secondary outcome [4]
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Patient-identified Most Bothersome Symptom
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Assessment method [4]
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Change in most bothersome symptom
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Timepoint [4]
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12-weeks
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Eligibility
Key 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.
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Minimum age
22
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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Genesis Research Services - Broadmeadow
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Recruitment hospital [2]
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Australian Medical Research - Hurstville
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Recruitment hospital [3]
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CerCare - Wayville
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Recruitment hospital [4]
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Paincare Perth - Perth
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Recruitment postcode(s) [1]
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- Broadmeadow
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Recruitment postcode(s) [2]
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- Hurstville
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Recruitment postcode(s) [3]
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- Wayville
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Recruitment postcode(s) [4]
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- Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ShiraTronics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05700318
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Scientific Advisory Board
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Address
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ShiraTronics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Fred Ecklund
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Address
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Country
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Phone
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1-844-228-7330
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05700318
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