REsponse to Combined SONS and ONS in Chronic Cluster HeadachE

Not Applicable

Active, not recruiting

• Conditions: Chronic Cluster Headache
• Interventions: Device: PRIMUS

• Registration Number: NCT05868044
• Lead Sponsor: Salvia BioElectronics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Primary Completion: 2024-04-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRIMUS	PRIMUS	PRIMUS system

Primary Outcome Measures

Name	Time	Method
Safety Evaluation	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.

Trial Locations

Locations (1)

Resolve Pain; 🇦🇺 Buderim, Queensland, Australia