Chronic Cluster HeadacheBONSNCT06124534
Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH
A study testing Neurostimulation of the Occipital Nerve Field in people with Chronic Cluster Headache, run by Man and Science, SA at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel BliStim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. This is a prospective, first in human study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- Neurostimulation of the Occipital Nerve Field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Oct 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Age range: 18-70 years
- Difficult-to-treat CCH with documented previous complete failure, insufficient efficacy, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.
- 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.
Show all 9Show fewer
- Subject written informed consent provided before enrolment
- Subject 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.
- Subject willing and able to comply with study-related requirements, procedures, and visits.
Who cannot join
- 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)
- Subjects suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
- Subjects at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS
- 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.
Show all 13Show fewer
- 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 transmission, suboccipital infiltrations with steroids and/or local anaesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids WHO 3.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Occipital Nerve Field Stimulation for the Prophylactic Treatment of Difficult-to-treat Chronic Cluster Headache
The purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel BliStim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. This is a prospective, first in human study.
- Conditions
- Chronic Cluster Headache
- Being tested
- Neurostimulation of the Occipital Nerve Field
- Keywords
- Cluster Headaches
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulation of the Occipital Nerve FieldDevice
BliStim Neurostimulation system
| Study group | Role | What they receive |
|---|---|---|
| Blistim System | Experimental | Occipital Nerve Stimulation using the BliStim Occipital Nerve Stimulator Receives: Device: Neurostimulation of the Occipital Nerve Field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation of the Device [Time Frame:12 weeks / 48 weeks]
The primary endpoint is safety and is assessed through the incidence of procedure related and/or device-related adverse events during the 12-weeks post implantation and the rate of all adverse events during the entire 48-week study period.
Measured: 12-weeks post implantation and through study completion at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start19 Oct 2023
- Primary completion21 Nov 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Why it stopped: device upgrade/requires competent authority approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Man and Science, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J-P Van Buyten, Principal investigator, VITAZ Hospital, Sint Niklaas, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124534
- Sponsor's protocol ID
- DOC-130
- Acronym
- BONS
- Status last verified
- Jun 2024
- First submitted
- 26 Oct 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Occipital Nerve Field Stimulation for the Prophylactic Treatment of Difficult-to-treat Chronic Cluster Headache
- ClinicalTrials.gov ID
- NCT06124534
- Acronym / sponsor ID
- BONS / DOC-130
- Conditions
- Chronic Cluster Headache
- Keywords
- Cluster Headaches
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: device upgrade/requires competent authority approval
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Man and Science, SAIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 21 Nov 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel BliStim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. This is a prospective, first in human study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blistim System | Experimental | Device: Neurostimulation of the Occipital Nerve FieldOccipital Nerve Stimulation using the BliStim Occipital Nerve Stimulator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Age range: 18-70 years
- Difficult-to-treat CCH with documented previous complete failure, insufficient efficacy, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.
Key exclusion criteria (13 listed)
- 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)
- Subjects suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
- Subjects at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurostimulation of the Occipital Nerve FieldBliStim Neurostimulation system | Device | Blistim System |
Primary outcome
Safety Evaluation of the Device [Time Frame:12 weeks / 48 weeks]
Time frame: 12-weeks post implantation and through study completion at 48 weeks
The primary endpoint is safety and is assessed through the incidence of procedure related and/or device-related adverse events during the 12-weeks post implantation and the rate of all adverse events during the entire 48-week study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Cluster Headache
Active, not recruitingPhase 2
Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache
Cluster Headache
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Not yet recruitingPhase 2
Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache
Cluster Headache
Active, not recruiting
Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD - a Pilot Study
Cluster Headache - Episodic and Chronic, Migraine Headache
Recruiting
Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD
Cluster Headache - Episodic and Chronic, Migraine Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J-P Van Buyten principal investigator
VITAZ Hospital, Sint Niklaas, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation of the Occipital Nerve Field in people with Chronic Cluster Headache, run by Man and Science, SA at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation of the Device [Time Frame:12 weeks / 48 weeks] (time frame: 12-weeks post implantation and through study completion at 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.