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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cluster Headache
• Intervention / Treatment: Device: Holter electrocardiogram

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 Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

• Study Contact: Name: Christelle CREAC'H, MD; Phone Number: +33 (0)4.77.12.76.48; Email: christelle.creach@chu-st-etienne.fr
• Study Contact Backup: Name: Fleur PETIT, CRA; Phone Number: +33 (0)4.77.82.95.58; Email: Fleur.petit@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Cluster Headache (CH) will be included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Cluster Headache (CH); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Christelle CREAC'H, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Autonomic Nervous System; Electrocardiogram; Cluster Headache; Seizure; Holter; (LF/HF) ratio; Daytime seizure; Night seizure
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: 19CH103; 2019-A01343-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No