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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05868044




Registration number
NCT05868044
Ethics application status
Date submitted
2/05/2023
Date registered
22/05/2023

Titles & IDs
Public title
REsponse to Combined SONS and ONS in Chronic Cluster headachE
Scientific title
REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study
Secondary ID [1] 0 0
SCI-01-CCH
Universal Trial Number (UTN)
Trial acronym
RESPONSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Cluster Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PRIMUS

Experimental: PRIMUS - PRIMUS system


Treatment: Devices: PRIMUS
PRIMUS system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Evaluation
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Safety Evaluation
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Resolve Pain - Buderim
Recruitment postcode(s) [1] 0 0
4556 - Buderim

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Salvia BioElectronics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Frank, MD
Address 0 0
Resolve Pain
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wim Pollet, MD
Address 0 0
Country 0 0
Phone 0 0
+32 498 57 98 98
Fax 0 0
Email 0 0
wim.pollet@salvianeuro.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05868044