RecruitingNot ApplicableNCT04937010
Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial
Sponsor
Alberta Health Services, Calgary
Enrollment
20 participants
Start Date
Feb 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria2
- Meets ICHD-3 diagnostic criteria for the chronic form of one of the trigeminal autonomic cephalgias (outlined below), as determined by the treating neurologist.
- Failed standard medical management, meaning at least 3 conventional preventative therapies.
Exclusion Criteria4
- Presence of uncontrolled or untreated psychiatric disease
- Presence of medical contraindications to surgery
- Patient does not consent to surgery
- Non-English speaking
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Interventions
PROCEDUREOccipital nerve stimulator implant
Implantation of occipital nerve stimulator and different stimulation parameters
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04937010