Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).

Centre Hospitalier Universitaire de Saint Etienne19 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cluster Headache

Interventions

Holter electrocardiogramDEVICE

Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient over 18 years of age * Affiliated or entitled to a Social Security scheme * Resident in the territories of the hospital grouping of Loire territory (located less than 50 km away) * Whose diagnosis of episodic or chronic Cluster Headache (CH) has been confirmed according to International Classification of Headache Disorders (ICHD)- 3 criteria * With a regular sinus rhythm and heart rate Exclusion Criteria: * Conditions contraindicating the use of injectable sumatriptan * Conditions likely to affect the Autonomic Nervous System (ANS): dysautonomic sensory neuropathies, sleep apnea syndrome, etc. * Cognitive or language disorders that may interfere with pain assessment and seizure follow-up. * Patients taking treatments that may modify the Autonomic Nervous System (ANS): catecholamine (adrenaline, noradrenaline, dopamine), B-stimulants (isoprenaline, dobutamine, dopexamine, salbutamol, terbutaline, fenoterol, orciprenaline, clenbuterol, salmeterol, formoterol), B-blockers, alpha-stimulants (midodrine, alpha-methyl-dopa, clonidine, rilmenidine, moxonidine), alpha-blockers (phentolamine, prazosin, urapidil), amphetamine, tyramine, ephedrine, selegiline, cocaine, imipramine. * Impossibility to submit to the medical follow-up of the program for geographical, social or psychological reasons. * Patient deprived of liberty or under guardianship. * Patient with preventive background treatment of Cluster Headache (CH).

Locations (1)

CHU Saint-Etienne

Saint-Etienne, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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