REsponse to Combined SONS and ONS in Chronic Cluster headachE

Chronic Cluster Headache Clinical Trial

— RESPONSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868044
• Other study ID #: SCI-01-CCH
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2024
• Source: Salvia BioElectronics
• Contact: Wim Pollet, MD
• Phone: +32 498 57 98 98
• Email: wim.pollet[@]salvianeuro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safe use of a novel cranio-facial Peripheral Nerve Stimulator PNS 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 PNS System for the treatment of chronic cluster headache.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 30, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache
• Headache

Intervention

Device:
• PRIMUS
Peripheral Nerve Stimulator System

Locations

Country	Name	City	State
Australia	Resolve Pain	Buderim	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Salvia BioElectronics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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