cluster headache suicide headache
Conditions
Interventions
Implantation of the ATI neurostimulator in the sphenopalatine ganglion
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -18-65 years old. -classified with chronic cluster headache ICHD-3 criteria 3.1.2 -reported headache frequentie of 10 weekly -Patient reported dissatisfaction with current headache treatments. -Patient was able to distinguish cluster headaches from other headaches. -knowledge dutch language
Exclusion criteria
Exclusion criteria: -Patient had a change in type or dosage of preventive headache medications within one month of enrollment. -Women of childbearing age who were pregnant, nursing, or not using contraception. -Patient had undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site within the last four months. -Patient had been treated with radiation to the facial region within the last six months. -Patient had been diagnosed with any major infectious processes including osteomyelitis or primary or secondary malignancies of the face that were active or required treatment in the past six months. Patient had another significant pain problem that might confound the study assessments in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic effect of the ATI neurostimulator in patients with refractory CH headache | — |
Secondary
| Measure | Time frame |
|---|---|
| -Quality of life -reduction in medication -cost-effectiveness analysis | — |
Countries
Netherlands
Outcome results
None listed