Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
ConditionTrigeminal Autonomic Cephalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAlberta Health Services, Calgary
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of uncontrolled or untreated psychiatric disease
Presence of medical contraindications to surgery
Patient does not consent to surgery
Non-English speaking
Trial design
Design model
Crossover
Treatments tested in this trial
Occipital nerve stimulator implant
Procedure/SurgeryImplantation of occipital nerve stimulator and different stimulation parameters
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Industry standard stimulationActive comparator 1 intervention
Group B: Experimental stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in headache frequency
Change in frequency of headaches
Time frame
6 monthsSecondary outcomes
1
Safety of Occipital Nerve Stimulation
Any adverse events with stimulation
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov