REsponse to Combined SONS and ONS in Chronic Cluster headachE

NCT05868044 | Active Not Recruiting

• 1 other identifier: SCI-01-CCH
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Cluster Headache

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

PRIMUS

EXPERIMENTAL

PRIMUS system

Device: PRIMUS

Interventions

PRIMUS DEVICE

PRIMUS system

PRIMUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salvia BioElectronics: lead

Study Sites (1)

Resolve Pain

Buderim, Queensland, 4556, Australia

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Paul Frank, MD

  Resolve Pain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 22, 2023
• Study Start: May 2, 2023
• Primary Completion: April 23, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)