REsponse to Combined SONS and ONS in Chronic Cluster HeadachE
NCT ID: NCT05868044
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
5 participants
INTERVENTIONAL
2023-05-02
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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PRIMUS
PRIMUS system
PRIMUS
PRIMUS system
Interventions
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PRIMUS
PRIMUS system
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Salvia BioElectronics
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Frank, MD
Role: PRINCIPAL_INVESTIGATOR
Resolve Pain
Locations
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Resolve Pain
Buderim, Queensland, Australia
Countries
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Other Identifiers
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SCI-01-CCH
Identifier Type: -
Identifier Source: org_study_id