Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Study Overview
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Brief Summary
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The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).

Detailed Description
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Several open studies and case series have shown improvement in pain scores using ONS specifically for cluster headache, which is the most common of the TACs. However, neuromodulation in the treatment of pain disorders is subject to strong placebo effect and bias, and the lack of controlled studies in this population makes its true efficacy unknown. Therefore, we plan to study ONS in a population of patients with chronic TACs using a double-blind, randomized, controlled, cross-over study. Using sub-threshold stimulation parameters, meaning patients will not know when therapeutic stimulation is active, subjects will rate their pain and quality of life during both therapeutic and sham stimulation periods. Following the cross-over period, all subjects will undergo therapeutic stimulation for 1-year in order to gauge long-term effects.

Official Title
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Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial

Conditions
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Trigeminal Autonomic Cephalgia

Intervention / Treatment
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* Procedure: Occipital nerve stimulator implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Presence of uncontrolled or untreated psychiatric disease Presence of medical contraindications to surgery Patient does not consent to surgery Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Industry standard stimulation<br>Standard sub threshold stimulation parameters | Procedure: Occipital nerve stimulator implant<br>* Implantation of occipital nerve stimulator and different stimulation parameters<br>|
| Sham Comparator: Experimental stimulation<br>Sham stimulation | Procedure: Occipital nerve stimulator implant<br>* Implantation of occipital nerve stimulator and different stimulation parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache frequency | Change in frequency of headaches | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Occipital Nerve Stimulation | Any adverse events with stimulation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occipital Nerve Stimulation