Study Using the ShiraTronics Migraine Therapy System | NCT05700318

Studies
Study Using the ShiraTronics Migraine Therapy System

NCT05700318

Sponsor

ShiraTronics

Status

Recruiting

Last Update Posted

Jul 16, 2024Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Chronic Migraine, Headache

Interventions

neurostimulator

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2023Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Jan 17, 2023

First Submission Date that Met QC Criteria

Jan 17, 2023

First Posted Date

Jan 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2024

Last Update Posted Date

Jul 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neurostimulation	Experimental	Neurostimulation will be delivered to target nerves.	Device: neurostimulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neurostimulator	Device	The ShiraTronics Migraine Therapy System	Neurostimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Monthly Headache Days	Change in number of mean monthly headache days	12-weeks

Secondary Outcomes

Measure	Description	Time Frame
50% reduction in mean Headache days	Proportion of subjects with 50% reduction in mean monthly headache days	12-weeks
Monthly Migraine Days	Change in mean monthly migraine days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants who are 22 years of age or older.
History of migraine ≥ 12 months.
Participants experiencing between 15 to 26 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation.
Inadequate response to, unwilling, or contraindicated to Onabotulinumtoxin A and CGRP monoclonal antibodies therapy.
Stable use of migraine medication.

Exclusion Criteria:

Post-traumatic headache.
Medication overuse headache.
New daily persistent headache.
Report experiencing unremitting, continuous headaches with no relief.
Previously implanted neurostimulator to treat headache.
History of cervical radiofrequency ablation or had any other intervention/device for migraine.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fred Ecklund	Contact	1-844-228-7330		fecklund@shiratronics.com

Overall Officials

Name	Affiliation	Role
Scientific Advisory Board	ShiraTronics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Genesis Research Services	Recruiting	Broadmeadow	New South Wales		Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058542	Implantable Neurostimulators

Ancestor Terms

ID	Term
D004567	Electrodes, Implanted
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided