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

NCT04439409 | Terminated

• 2 other identifiers: 19CH1032019-A01343-54
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Headache

Keywords

Cluster Headache; Autonomic Nervous System; Seizure; Holter; Electrocardiogram; (LF/HF) ratio; Daytime seizure; Night seizure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure

  Day: 7

• Low Frequency during daytime and night seizure

  Day: 7

• High Frequency (HF) during daytime and night seizure

  Day: 7

• Correlation between several parameters

  Day: 7

Study Arms (1)

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

Interventions

Holter electrocardiogram DEVICE

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

Patients with Cluster Headache (CH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Cluster Headache (CH) will be included.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Cluster Headache; Seizures

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christelle CREAC'H, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: August 19, 2020
• Primary Completion: December 7, 2021
• Study Completion: December 15, 2021
• Last Updated: October 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)