Status:
TERMINATED
Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Cluster Headache
Eligibility:
All Genders
18+ years
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 Headac...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04439409
Start Date
August 19 2020
End Date
December 15 2021
Last Update
October 27 2023
Active Locations (1)
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1
CHU Saint-Etienne
Saint-Etienne, France