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SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Active SENGO | Active Comparator | The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted. |
|
| Arm sham SENGO | Placebo Comparator | The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| great occipital nerve stimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| number of headache days during the 14 days withdrawal period | 14 days | |
| maximal intensity and duration of rebound headache | 14 days | |
| rescue medication used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FONTAINE Denys, PhD | Neurosurgery depatment - CHU Pasteur, Nice | Study Chair |
| LANTERI-MINET Michet, PhD | Neurosurgery department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology department - La timone | Marseille | France | ||||
| Neurosurvery department |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 14 days |
| withdrawal facility perceived by the patient | 14 days |
| Nice |
| France |
| Headache Emergency Center | Paris | France |
| Neurology department - CHU Rangueil | Toulouse | France |