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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01343-54 | Other Identifier | ANSM |
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No inclusions for 2 years
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Cluster Headache (CH) is associated with ipsilateral vegetative signs, related to parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. The precise mechanism of Cluster Headache (CH) is still unknown. The question is whether these dysautonomic disorders are simply secondary to the Cluster Headache (CH) process or whether they are the triggering factor.
This study cares about the evolution of the Autonomic Nervous System (ANS) in Cluster Headache (CH) seizures. Patients will be offered Holter ECG to study the temporal relationships between changes in Autonomic Nervous System (ANS) activity during Headache (CH) seizures and changes in Autonomic Nervous System (ANS) activity before and after seizure treatment, using heart rate variability measurement.
The hypothesis is that there would be an initial temporary sympathetic activation, followed quickly by parasympathetic hyperactivation and a return to a state of equilibrium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Cluster Headache (CH) | Patients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holter electrocardiogram | Device | Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure | Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure during the basal period, pre-seizure, seizure and after the seizure. | Day: 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure | Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure during the basal period, pre-seizure, seizure and after the seizure. | Day: 7 |
| Low Frequency during daytime and night seizure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Cluster Headache (CH) will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Christelle CREAC'H, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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Comparison of measure of Low Frequency during daytime and night seizure. |
| Day: 7 |
| High Frequency (HF) during daytime and night seizure | Comparison of measure of High Frequency (HF) during daytime and night seizure. | Day: 7 |
| Correlation between several parameters | Correlation between Heart Rate Variability (HRV), changes in the Low Frequency/High Frequency (LF/HF) ratio, the Low Frequency (LF) and the High Frequency (HF), and the intensity of pain measured on the Visual Analog Scale (VAS). | Day: 7 |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |