REsponse to Combined SONS and ONS in Chronic Cluster headachE (RESPONSE)

April 22, 2026 updated by: Salvia BioElectronics

REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study

The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Buderim, Queensland, Australia, 4556
        • Resolve Pain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRIMUS
PRIMUS system
Device: PRIMUS
PRIMUS system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Evaluation
Time Frame: 4 weeks
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
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salvia BioElectronics

Investigators

  • Principal Investigator: Paul Frank, MD, Resolve Pain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

April 23, 2024

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-01-CCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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