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

Salvia BioElectronics

Status

Active, not recruiting

Conditions

Chronic Cluster Headache

Treatments

Device: PRIMUS

Study type

Interventional

Funder types

Industry

Identifiers

NCT05868044

SCI-01-CCH

Details and patient eligibility

About

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.

Enrollment

5 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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