REsponse to Combined SONS and ONS in Chronic Cluster head... | NCT05868044

Studies
REsponse to Combined SONS and ONS in Chronic Cluster headachE

NCT05868044

Sponsor

Salvia BioElectronics

Status

Active, not recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Chronic Cluster Headache

Interventions

PRIMUS

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

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2023Actual

Primary Completion Date

Apr 23, 2024Actual

Completion Date

Dec 30, 2026Estimated

First Submitted Date

May 2, 2023

First Submission Date that Met QC Criteria

May 11, 2023

First Posted Date

May 22, 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

Apr 22, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

5Estimated

Label	Type	Description	Intervention Names
PRIMUS	Experimental	PRIMUS system	Device: PRIMUS

Name	Type	Description	Arm Group Labels	Other Names
PRIMUS	Device	PRIMUS system	PRIMUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Evaluation	The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days.	4 weeks
Safety Evaluation	The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at the end of the study.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Able and willing to provide informed consent
Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
Stable on preventive treatment for at least two weeks prior to enrolment.
Agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study
MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
Able and willing to complete a headache Diary

Main Exclusion Criteria:

Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms
Concomitant neuromodulation, except tVNS
Previous failure to any implantable neuromodulation device for neurovascular headache
Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
Metal implants in the skull (e.g. skull plates, seeds) nearby the implant
Have a pacemaker or implantable cardioverter defibrillator (ICD)
Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months
Use of botulinum toxin injections in the past 12 weeks
Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment
Women of childbearing age who are pregnant, nursing or not using contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases