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

NCT ID: NCT04439409

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2021-12-15

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.

Conditions

Cluster Headache

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Cluster Headache (CH)

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

Holter electrocardiogram

Intervention Type: DEVICE

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

Interventions

Holter electrocardiogram

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle CREAC'H, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2019-A01343-54

Identifier Type: OTHER

Identifier Source: secondary_id

19CH103

Identifier Type: -

Identifier Source: org_study_id