Chronic Cluster HeadacheONFIELDNCT07677137
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.
A study testing Occipital Nerve Stimulation System in people with Chronic Cluster Headache, run by Man and Science, SA at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- Occipital Nerve Stimulation System
- 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
- 18 May 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 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 1 year
- 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 efficacy, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.
Show all 11Show fewer
- 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.
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)
- 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.
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 anesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids WHO 3. Oral or systemic steroids are not allowed during the month before enrolment, except low doses (prednisone not superior to 10mg/day for no more than 7 days) if needed for other disorders.
- 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. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
VITAZ
Sint-Niklaas, 9100
Tamy Bonte, +32 3 760 2318, pijncentrum@vitaz.be
Iris Smet, MD
About this study
Official title: A Monocentric, Single-arm, Single-blind Withdrawal 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.
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:
Read more
- What adverse events or medical complications occur following ONSS implantation and stimulation?
- Does treatment with the ONSS reduce the frequency of cluster headache attacks compared with baseline?
Participant Involvement
Participants will:
- Undergo implantation of the ONSS device.
- Use the ONSS for a 48-week treatment period.
- Attend scheduled clinic visits for follow-up assessments and device evaluations.
- Maintain a diary documenting cluster headache attacks and use of rescue medications.
- Complete study-related assessments throughout the study period.
- Conditions
- Chronic Cluster Headache
- Being tested
- Occipital Nerve Stimulation System
- 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.
Occipital Nerve Stimulation SystemDevice
48 weeks of daily stimualtion with ONS System
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Occipital nerve stimulation using the Occipital Nerve Stimulation System Receives: Device: Occipital Nerve Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedure-related or device-related adverse events at 12 weeks
Measured: From implantation to 12 weeks post implantation
Number of adverse events at 48 weeks
Measured: From implantation to 48 weeks post-activation
Secondary outcomes (6)
Change in the mean weekly attack frequency
Measured: From enrollment to 48 weeks post-activation
50% Responder rate
Proportion of subjects achieving a ≥ 50% reduction in mean weekly attack frequency compared to baseline
Measured: From enrollment to 48 weeks post-activation
30% Responder rate
Proportion of subjects achieving a ≥ 30% reduction in mean weekly attack frequency compared to baseline
Measured: From enrollment to 48 weeks post-activation
Change in the mean weekly attack intensity compared to baseline
Intensity is assessed using a 5-point ordinal pain scale from 0-no pain to 4-the worst pain
Measured: From enrollment to 48 weeks post-activation
Change in the mean number of weekly attack treatments compared to baseline
Attack treatments include but are not limited to triptan injections or nasal sprays or pills, 02 inhalations
Measured: From enrollment to 48 weeks post-activation
Scalp distribution of stimulation-induced paraesthesia per scalp region assessed using an 18-region scalp mapping tool
Scalp distribution of stimulation-induced paraesthesia will be assessed weekly and recorded in the participant's electronic diary. Participants will indicate the location(s) of perceived paraesthesia on a standardized scalp map divided into 18 predefined regions. The distribution will be quantified as the percentage of reported paraesthesia across these regions.
Measured: From enrollment to 48 weeks post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start18 May 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677137
- Sponsor's protocol ID
- R-00179
- Other IDs
- CIV-26-02-056414
- Acronym
- ONFIELD
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Single-arm, Single-blind Withdrawal 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
- Acronym / sponsor ID
- ONFIELD / R-00179
- Conditions
- Chronic Cluster Headache
- Keywords
- Cluster Headaches
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Man and Science, SAIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jun 2026 (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 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?
- Does treatment with the ONSS reduce the frequency of cluster headache attacks compared with baseline?
Participant Involvement
Participants will:
- Undergo implantation of the ONSS device.
- Use the ONSS for a 48-week treatment period.
- Attend scheduled clinic visits for follow-up assessments and device evaluations.
- Maintain a diary documenting cluster headache attacks and use of rescue medications.
- Complete study-related assessments throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Occipital Nerve Stimulation SystemOccipital nerve stimulation using the Occipital Nerve Stimulation System |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ICHD-3 criteria for chronic cluster headache
- Documented history of CCH since at least 1 year
- 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
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)
- 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
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 |
|---|---|---|
| Occipital Nerve Stimulation System48 weeks of daily stimualtion with ONS System | Device | Active treatment |
Primary outcome
Number of procedure-related or device-related adverse events at 12 weeks
Time frame: From implantation to 12 weeks post implantation
Number of adverse events at 48 weeks
Time frame: From implantation to 48 weeks post-activation
6 secondary outcomes
Change in the mean weekly attack frequency
Time frame: From enrollment to 48 weeks post-activation
50% Responder rate
Time frame: From enrollment to 48 weeks post-activation
30% Responder rate
Time frame: From enrollment to 48 weeks post-activation
Change in the mean weekly attack intensity compared to baseline
Time frame: From enrollment to 48 weeks post-activation
Change in the mean number of weekly attack treatments compared to baseline
Time frame: From enrollment to 48 weeks post-activation
Scalp distribution of stimulation-induced paraesthesia per scalp region assessed using an 18-region scalp mapping tool
Time frame: From enrollment to 48 weeks post-activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Related trials for Chronic 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
RecruitingObservational study
Italian Trigeminal Autonomic Cephalalgias Assessment Study
Trigeminal Autonomic Cephalalgias, Cluster 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipital Nerve Stimulation System 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 11 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle Nguepi (+34 613 581 071, c.nguepi@manandscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of procedure-related or device-related adverse events at 12 weeks (time frame: From implantation to 12 weeks post implantation). The study lists 2 primary outcomes in all. 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 27 Aug 2026.