Chronic Cluster Headache Headache
Conditions
Interventions
The MySalvia System consists of:Two thin implants: one 25 cm implant placed under the skin of the forehead and one 17 cm implant placed under the skin at the back of the head.MySalvia device: an exter
Sponsors
Salvia BioElectronics B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Able and willing to provide informed consent18 years of age or olderDocumented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteriaAttack frequency of = 4 attacks per week for = 4 weeks before enrolment (to be confirmed during baseline diary collection)Documented failure of verapamil (failure meaning ineffective at the highest tolerable dose, or provoked unacceptable side effects)Stable on preventive treatment (pharmacological and non-pharmacological preventive treatments) for at least 4 weeks before enrolment Agree to refrain from starting new or changing the dose of preventive cluster headache drugs from 4 weeks before entering the baseline period and during the first 6 months of the studyMRI available or willing to undergo an MRI to exclude structural lesions potentially causing cluster headacheAble and willing to complete a headache eDiaryAble and willing to comply with the requirements of the study visit schedule and self-assessment questionnairesInclusion criteria to be assessed at the end of the screening phase and to be confirmed prior to entering the randomized treatment phase.Have = 4 attacks per week in the 28-day baseline diary
Exclusion criteria
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 symptomsSecondary Cluster Headache Headache location mainly in the distribution area of V2, V3Concomitant neuromodulation, except transcutaneous Vagal Nerve Stimulation (tVNS)Previous failure to an implantable neuromodulation device for neurovascular headacheHave 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 implantHave a pacemaker or implantable cardioverter defibrillator (ICD)Suboccipital infiltrations with steroids and/ or local anaesthetics in the past 12 weeks prior to enrolment.Use of botulinum toxin injections in the past 12 weeks (for other medical or cosmetic reasons) prior to enrolmentCalcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolmentWomen of childbearing age who are pregnant, nursing, or not using contraceptionKnown to require an MRI scan during the studyPsychiatric disorder or medical condition that would, in the opinion of the investigator, interfere with the outcome of the studyConfounding pain conditions other than cluster headache (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome), which could interfere with study procedures or pain reporting, as determined by the investigatorPlanning to start new preventive therapies for cluster headache (pharmacological and non-pharmacological) Concomitant participation or planning to participate in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the RESPONSE-II study is the safety of the MySalvia System. This is assessed by monitoring the number and type of serious adverse events related to the implantation procedure or to the device itself. Safety is continuously evaluated throughout the entire study, with particular focus during the first 12 weeks and at all subsequent follow-up visits. All adverse events and device deficiencies with the system are systematically collected and recorded during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Besides safety (the main goal), the study also looks at whether the MySalvia System can help reduce cluster headache attacks and improve daily life. Researchers will measure:Attack reduction – whether patients have fewer attacks per week, and how many achieve at least 30%, 50%, 75% or even 90% fewer attacks.Attack characteristics – changes in the average length and severity of attacks.Rescue medication use – whether patients need less acute medication (like triptans or oxygen).Prevention of attacks – whether stimulation can stop an attack from fully breaking through when it starts.Quality of life – improvement in daily functioning, mood, anxiety, and overall well-being, measured through questionnaires.Satisfaction and ease of use – how patients experience the MySalvia device in daily life.Long-term effects – whether benefits seen after 6 months are still present after 1 and 2 years. | — |
Countries
Netherlands
Contacts
Public ContactW P Pollet
Salvia BioElectronics B.V.
Outcome results
None listed