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REsponse to Combined SONS and ONS in Chronic Cluster headachE (RESPONSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05868044
Recruitment Status : Recruiting
First Posted : May 22, 2023
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
Salvia BioElectronics

Study Description
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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
Chronic Cluster Headache Device: PRIMUS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study
Actual Study Start Date : May 2, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRIMUS
PRIMUS PNS System
 Device: PRIMUS
Peripheral Nerve Stimulator System


Outcome Measures
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Primary Outcome Measures :
  1. Safety Evaluation [ Time Frame: 4 weeks ]
    The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days.

  2. Safety Evaluation [ Time Frame: 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 exposure to any implantable neuromodulation device
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05868044


Contacts
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Contact: Wim Pollet, MD +32 498 57 98 98 wim.pollet@salvianeuro.com

Locations
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Australia, Queensland
Resolve Pain Recruiting
Buderim, Queensland, Australia, 4556
Contact: Paul Frank, MD       clinicaltrial@resolvepain.com.au   
Sponsors and Collaborators
Salvia BioElectronics
Investigators
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Principal Investigator: Paul Frank, MD Resolve Pain
More Information
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Responsible Party: Salvia BioElectronics
ClinicalTrials.gov Identifier: NCT05868044    
Other Study ID Numbers: SCI-01-CCH
First Posted: May 22, 2023    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
 Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases