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Tests treatment safety and results for Chronic Cluster Headache
Official title A First-in-human Study to Assess the Initial Safety, Tolerability, and Effectiveness of the ONSS Bilateral Occipital Nerve Field Stimulation System for the Prophylactic Treatment of Chronic Cluster Headache in Difficult-to-treat Subjects.
ClinicalTrials.gov ID: NCT07677137
What this study is testing
- What it's testing
- The purpose of this clinical trial is to evaluate the safety and effectiveness of the Occipital Nerve Stimulation System (ONSS) in treating chronic cluster headache in adults. The study aims to answer the following questions: What adverse events or medical complications occur following ONSS implantation and stimulation?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- ICHD-3 criteria for chronic cluster headache
- Documented history of CCH since at least 2 years
- Minimum mean attack frequency of 4 attacks per week at baseline (-4week to +2 week up to implant)
- Documented minimum 4 weeks of retrospective cluster headache diary data
- Age range: 22-70 years
You likely can't join if
- Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
- History of epilepsy, current treatment of epilepsy
- Documented history of cerebrovascular accident (CVA)
- Participants suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria...
- Participants at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS at screening
- Having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain...
See the full eligibility criteria
- ICHD-3 criteria for chronic cluster headache
- Documented history of CCH since at least 2 years
- Minimum mean attack frequency of 4 attacks per week at baseline (-4week to +2 week up to implant)
- Documented minimum 4 weeks of retrospective cluster headache diary data
- Age range: 22-70 years
- Difficult-to-treat CCH with documented previous complete failure, insufficient how well it works, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital...
- No preventive CH treatment or stable preventive CH medication for ≥ 2 weeks before enrolment. Subject agrees not to change existing treatment during the whole duration of the trial.
- Participant written informed consent provided before enrolment
- Participant willing and capable of subjective evaluation and to fill in an electronic CH diary, to understand questionnaires, and to read, understand and sign the written informed consent form.
- Partcipant willing and able to comply with study-related requirements, procedures, and visits.
- Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
- History of epilepsy, current treatment of epilepsy
- Documented history of cerebrovascular accident (CVA)
- Participants suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
- Participants at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS at screening
- Having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain hypothalamic stimulator, and/or a drug delivery pump, etc.
- Cranial botulinum toxin injections in the past 3 months before enrolment. Administration of the following treatments in the last month before enrolment: monoclonal antibodies blocking calcitonin gene-related peptide...
- Medication overuse headache (ICHD 3 8.2)
- Inability to fill out an electronic diary.
- Previous surgery or trauma involving the cervical spine or the occipital bone
- Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.
- Concurrent participation in another clinical study
- Planned pregnancy, pregnancy, or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Sint-Niklaas, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sint-Niklaas, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.