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Active, not recruitingNCT07677137ONFIELDUpdated Nov 10, 2026

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.

An interventional study of Occipital Nerve Stimulation System in Chronic Cluster Headache, sponsored by Man and Science, SA. Active, not recruiting at 1 site in Belgium. Open to participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Man and Science, SA · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
22 Years to 70 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Chronic Cluster Headache

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Keywords

  • Cluster Headaches
03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's planned enrollment of 10 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

Man and Science, SA is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ICHD-3 criteria for chronic cluster headache
  2. Documented history of CCH since at least 1 year
  3. Minimum mean attack frequency of 4 attacks per week at baseline (-4week to +2 week up to implant)
  4. Documented minimum 4 weeks of retrospective cluster headache diary data
  5. Age range: 22-70 years
  6. Difficult-to-treat CCH with documented previous complete failure, insufficient efficacy, intolerance, or to most preventive CH treatments among which are oral or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.

  7. 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.

  8. Participant written provided before enrolment
  9. 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.
  10. Partcipant willing and able to comply with study-related requirements, procedures, and visits.

Exclusion criteria

Exclusion Criteria:

  1. Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
  2. History of epilepsy, current treatment of epilepsy
  3. Documented history of cerebrovascular accident (CVA)
  4. Participants suffering from a substance use disorder, as defined by (DSM) criteria. Recreational use of cannabis is allowed.
  5. Participants at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS at screening
  6. 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.
  7. 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 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.
  8. Medication overuse headache (ICHD 3 8.2)
  9. Inability to fill out an electronic diary.
  10. Previous surgery or trauma involving the cervical spine or the occipital bone
  11. Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.
  12. Concurrent participation in another clinical study
  13. Planned pregnancy, pregnancy, or breastfeeding.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Active treatment

    Occipital nerve stimulation using the Occipital Nerve Stimulation System

    Device: Occipital Nerve Stimulation System

Interventions

  • DeviceOccipital Nerve Stimulation System

    48 weeks of daily stimualtion with ONS System

06

What researchers measure

Primary outcomes

  1. Number of procedure-related or device-related adverse events at 12 weeks

    Time frame: From implantation to 12 weeks post implantation

  2. Number of adverse events at 48 weeks

    Time frame: From implantation to 48 weeks post-activation

Secondary outcomes

  1. Change in the mean weekly attack frequency

    Time frame: From enrollment to 48 weeks post-activation

  2. 50% Responder rate

    Proportion of subjects achieving a ≥ 50% reduction in mean weekly attack frequency compared to baseline

    Time frame: From enrollment to 48 weeks post-activation

  3. 30% Responder rate

    Proportion of subjects achieving a ≥ 30% reduction in mean weekly attack frequency compared to baseline

    Time frame: From enrollment to 48 weeks post-activation

  4. 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

    Time frame: From enrollment to 48 weeks post-activation

  5. 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

    Time frame: From enrollment to 48 weeks post-activation

  6. 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.

    Time frame: From enrollment to 48 weeks post-activation

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Oct 2027, 17 months after the start.

Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's planned 17 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Jul 2027 → Oct 2027 and completion Jul 2027 → Oct 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jun 30, 2026
StartActual
May 18, 2026
Primary completionEst.
Oct 2027was Jul 2027
CompletionEst.
Oct 2027was Jul 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Nov 10, 2026
Primary completion
Jul 2027→Oct 2027
Nov 10, 2026
Study completion
Jul 2027→Oct 2027
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Recruiting→Active, not recruiting
    Primary completion Jul 2027→Oct 2027
    Study completion Jul 2027→Oct 2027
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07677137
Lead sponsor
Man and Science, SA
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
May 18, 2026
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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