RESPONSE: REsponse to Combined SONS and ONS in Chronic Cluster headachE
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PRIMUS PRIMUS PNS System |
Device: PRIMUS
Peripheral Nerve Stimulator System
|
Outcome Measures
Primary Outcome Measures
- 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.
- Safety Evaluation [12 weeks]
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.
Eligibility Criteria
Criteria
Main Inclusion Criteria:
-
Able and willing to provide informed consent
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Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
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Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
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Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
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Stable on preventive treatment for at least two weeks prior to enrolment.
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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
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MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
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Able and willing to complete a headache Diary
Main Exclusion Criteria:
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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
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Concomitant neuromodulation, except tVNS
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Previous exposure to any implantable neuromodulation device
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Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
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Metal implants in the skull (e.g. skull plates, seeds) nearby the implant
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Have a pacemaker or implantable cardioverter defibrillator (ICD)
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Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months
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Use of botulinum toxin injections in the past 12 weeks
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Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment
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Women of childbearing age who are pregnant, nursing or not using contraception
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Resolve Pain | Buderim | Queensland | Australia | 4556 |
Sponsors and Collaborators
- Salvia BioElectronics
Investigators
- Principal Investigator: Paul Frank, MD, Resolve Pain
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCI-01-CCH