An observational study in Cluster Headache, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational
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.
120 studies on the registry are indexed under Cluster Headache; 28 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 31 observational studies indexed under Cluster Headache.
Browse Cluster Headache studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Patients with Cluster Headache (CH) will be included.
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Exclusion Criteria:
Patients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days.
Device: Holter electrocardiogram
Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously.
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.
Time frame: Day: 7
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.
Time frame: Day: 7
Low Frequency during daytime and night seizure
Comparison of measure of Low Frequency during daytime and night seizure.
Time frame: Day: 7
High Frequency (HF) during daytime and night seizure
Comparison of measure of High Frequency (HF) during daytime and night seizure.
Time frame: 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).
Time frame: Day: 7
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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