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

Terminated

• Conditions: Cluster Headache
• Interventions: Device: Holter electrocardiogram

• Registration Number: NCT04439409
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2020-08-19
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Cluster Headache (CH)	Holter electrocardiogram	Patients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days.

Primary Outcome Measures

Name	Time	Method
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure	Day: 7	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.

Secondary Outcome Measures

Name	Time	Method
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure	Day: 7	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.
Low Frequency during daytime and night seizure	Day: 7	Comparison of measure of Low Frequency during daytime and night seizure.
High Frequency (HF) during daytime and night seizure	Day: 7	Comparison of measure of High Frequency (HF) during daytime and night seizure.
Correlation between several parameters	Day: 7	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).

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France