Stimulation of the sphenopalatine ganglion with the ATI Neurostimulation system for cluster headache treatment

Phase 3

Completed

• Conditions: cluster headache; suicide headache; 10019231

• Registration Number: NL-OMON44572
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Therapeutic effect of the ATI neurostimulator in patients with refractory CH<br /><br>headache</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Quality of life<br /><br>-reduction in medication<br /><br>-cost-effectiveness analysis</p><br>