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

Cluster Headache Clinical Trial

— AVASNA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04439409
• Other study ID #: 19CH103
• Secondary ID: 2019-A01343-54
• Status: Terminated
• Start date: August 19, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 15, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Low Frequency during daytime and night seizure	Comparison of measure of Low Frequency during daytime and night seizure.	Day: 7
Secondary	High Frequency (HF) during daytime and night seizure	Comparison of measure of High Frequency (HF) during daytime and night seizure.	Day: 7
Secondary	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