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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Industry standard stimulation | Active Comparator | Standard sub threshold stimulation parameters |
|
| Experimental stimulation | Sham Comparator | Sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occipital nerve stimulator implant | Procedure | Implantation of occipital nerve stimulator and different stimulation parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in headache frequency | Change in frequency of headaches | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Occipital Nerve Stimulation | Any adverse events with stimulation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fady Girgis, MD | Contact | 4039446497 | fmgirgis@ucalgary.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N2T9 | Canada |
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| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |