Study Using the ShiraTronics Migraine Therapy System

Not Applicable

Recruiting

• Conditions: Chronic Migraine, Headache
• Interventions: Device: neurostimulator

• Registration Number: NCT05700318
• Lead Sponsor: ShiraTronics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Study Start: 2023-05-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurostimulation	neurostimulator	Neurostimulation will be delivered to target nerves.

Primary Outcome Measures

Name	Time	Method
Monthly Headache Days	12-weeks	Change in number of mean monthly headache days

Secondary Outcome Measures

Name	Time	Method
50% reduction in mean Headache days	12-weeks	Proportion of subjects with 50% reduction in mean monthly headache days
Migraine Disability Assessment Test	12-weeks	Change in disability score
Monthly Migraine Days	12-weeks	Change in mean monthly migraine days
Patient-identified Most Bothersome Symptom	12-weeks	Change in most bothersome symptom

Trial Locations

Locations (4)

Genesis Research Services; 🇦🇺 Broadmeadow, New South Wales, Australia

CerCare; 🇦🇺 Wayville, South Australia, Australia

Australian Medical Research; 🇦🇺 Hurstville, New South Wales, Australia

Paincare Perth; 🇦🇺 Perth, Western Australia, Australia