Chronic Cluster Headache
Conditions
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.
Interventions
DEVICEPRIMUS
PRIMUS system
Sponsors
Salvia BioElectronics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | 4 weeks | The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORPaul Frank, MD
Resolve Pain
Outcome results
None listed