Could a Brain-Zapping implant tame cluster headaches?
NCT ID NCT07677137
First seen Jun 30, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study tests an implanted device that stimulates nerves at the back of the head to prevent chronic cluster headaches. Ten adults with difficult-to-treat cluster headaches will receive the implant and use it daily for 48 weeks. Researchers will track side effects and whether the device reduces the number of headache attacks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Occipital Nerve Stimulation System (implanted device)
- What this could lead to
- If it works, this could offer a new option for people with chronic cluster headaches who have not responded to other treatments.
- What could go wrong
- This is a very early, small study with only 10 participants. The device requires surgery, and risks include infection or device-related complications. Success is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 contra-indications to most preventive CH treatments among which are oral steroids 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 informed consent 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: 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 Diagnostic and Statistical Manual of Mental Disorders (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 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VITAZ
RECRUITINGSint-Niklaas, 9100, Belgium
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