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

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Cluster Headache

Treatments

Device: Holter electrocardiogram

Study type

Observational

Funder types

Other

Identifiers

NCT04439409

19CH103

2019-A01343-54 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).