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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

Titles & IDs
Public title
Study Using the ShiraTronics Migraine Therapy System
Scientific title
A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
Secondary ID [1] 0 0
STCM01
Universal Trial Number (UTN)
Trial acronym
RELIEV-CM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Migraine, Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Monthly Headache Days
Timepoint [1] 0 0
12-weeks
Secondary outcome [1] 0 0
50% reduction in mean Headache days
Timepoint [1] 0 0
12-weeks
Secondary outcome [2] 0 0
Monthly Migraine Days
Timepoint [2] 0 0
12-weeks
Secondary outcome [3] 0 0
Migraine Disability Assessment Test
Timepoint [3] 0 0
12-weeks
Secondary outcome [4] 0 0
Patient-identified Most Bothersome Symptom
Timepoint [4] 0 0
12-weeks

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.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Australian Medical Research - Hurstville
Recruitment hospital [3] 0 0
CerCare - Wayville
Recruitment hospital [4] 0 0
Paincare Perth - Perth
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Hurstville
Recruitment postcode(s) [3] 0 0
- Wayville
Recruitment postcode(s) [4] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ShiraTronics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scientific Advisory Board
Address 0 0
ShiraTronics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fred Ecklund
Address 0 0
Country 0 0
Phone 0 0
1-844-228-7330
Fax 0 0
Email 0 0
fecklund@shiratronics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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