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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04439409

Collaborator

(none)

Enrollment

Location

21.4

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cluster Headache	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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 19, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).