Status:
RECRUITING
Resting State Functional Connectivity in Cluster Headache
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Conditions:
Cluster Headache
Headache Disorders
Eligibility:
All Genders
18-70 years
Brief Summary
Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, a...
Detailed Description
Electroencephalogram (EEG) is widely available as a powerful mean to non-invasively study brain connectivity. High density EEG (HD-EEG), enables to record electrical brain activity with high temporal ...
Eligibility Criteria
Inclusion
- Diagnosis of 3.1.1 episodic cluster headache, or 3.1.2 chronic cluster headache, according to the International Classification of Headache Disorders-3 (ICHD-3) criteria
- History of at least 1 year of disease
- For the active-phase recording (T0) in eCH, no preventive medication ongoing or verapamil at a stable dose for at least 2 weeks
- For the remission-phase recording (T1), no preventive medication ongoing, and at least 14 headache-free days since preventive discontinuation
Exclusion
- Previous or actual history of epilepsy
- Diagnosis of dementia o mental retardation
- Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V
- Other concomitant type of headache (except for sporadic tension type headache)
- Chronic pain conditions
- Pregnancy or breastfeeding
- Concomitant use of electrical stimulators, pace-makers, metallic clips or other metallic foreign bodies
- Previous head surgery
- Ongoing neuroactive prevention therapies or other drugs, or psychoactive substances possibly interfering with EEG recording (eg benzodiazepines)
- Other conditions possibly influencing EEG recording
- Brain anomalies detected on MRI
- Healthy controls (HCs)
- Inclusion Criteria:
- Age and sex-matched healthy volunteers, without history of headache disorders except sporadic tension-type headache according to ICHD-3 criteria
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06206772
Start Date
November 1 2021
End Date
February 1 2025
Last Update
January 16 2024
Active Locations (1)
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1
Headache Science & Neurorehabilitation Center
Pavia, Italy, 27100