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RecruitingNCT05700318RELIEV-CMUpdated Jul 16, 2024

Study Using the ShiraTronics Migraine Therapy System

An interventional study of neurostimulator in Chronic Migraine, Headache, sponsored by ShiraTronics. Recruiting at 4 sites in Australia. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.

Sponsored by ShiraTronics · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Migraine, Headache
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

ShiraTronics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Neurostimulation

    Neurostimulation will be delivered to target nerves.

    Device: neurostimulator

Interventions

  • Deviceneurostimulator

    The ShiraTronics Migraine Therapy System

06

What researchers measure

Primary outcomes

  1. Monthly Headache Days

    Change in number of mean monthly headache days

    Time frame: 12-weeks

Secondary outcomes

  1. 50% reduction in mean Headache days

    Proportion of subjects with 50% reduction in mean monthly headache days

    Time frame: 12-weeks

  2. Monthly Migraine Days

    Change in mean monthly migraine days

    Time frame: 12-weeks

  3. Migraine Disability Assessment Test

    Change in disability score

    Time frame: 12-weeks

  4. Patient-identified Most Bothersome Symptom

    Change in most bothersome symptom

    Time frame: 12-weeks

07

Study locations

4 of 4 sites recruiting
  • Genesis Research Services
    Broadmeadow, New South Wales, Australia
    • · Contact · +61 2 4985 1860
    Recruiting
  • Australian Medical Research
    Hurstville, New South Wales, Australia
    • · Contact · +61 (02) 9570 5550
    Recruiting
  • CerCare
    Wayville, South Australia, Australia
    • · Contact · +61 410 567 855
    Recruiting
  • Paincare Perth
    Perth, Western Australia, Australia
    • · Contact · +61 8 9284 6005
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05700318
Lead sponsor
ShiraTronics
Responsible party
Sponsor
First posted
Jan 26, 2023
Start date
May 5, 2023
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Jul 16, 2024

Study contacts

Fred Ecklund
Contact
fecklund@shiratronics.com
1-844-228-7330
Scientific Advisory Board
study director · ShiraTronics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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