Clusterheadache Implantation and Neurostimulation Technology and Health Assessment
Recruiting
- Conditions
- cluster headacheclusterhoofdpijnsphenopalatinestimulatorneurostimulator
- Registration Number
- NL-OMON21021
- Lead Sponsor
- Stichting VU-VU Medisch CentrumDe Boelelaan 11171081 HV Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
18-65 years old.
-classified with chronic cluster headache ICHD-3 criteria 3.1.2
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the therapeutic effect of the ATI NeurostimulationSystem in patients with drug-resistant chronic cluster headaches in the Netherlands
- Secondary Outcome Measures
Name Time Method To demonstrate changes in quality of life in patients treated with the ATI NeurostimulationSystem <br /><br>To demonstrate a reduction in acute and preventative pharmacological treatment in patients treated with the ATI NeurostimulationSystem <br /><br>To determine the cost-effectiveness of implementation of the ATI NeurostimulationSystem per chronic cluster headache patient<br>