Resting State Functional Connectivity in Cluster Headache

Launched by IRCCS NATIONAL NEUROLOGICAL INSTITUTE "C. MONDINO" FOUNDATION · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how brain connectivity works in people who suffer from cluster headaches, which are very painful and recurring headaches that often happen in cycles. Researchers want to learn more about the differences in brain activity when patients are experiencing headaches compared to when they are headache-free. They will also compare these findings with healthy volunteers to see how brain function differs in those without headache disorders.

To participate, individuals must be diagnosed with either episodic or chronic cluster headaches and have a history of the condition for at least a year. They cannot be currently taking certain headache prevention medications or have other significant health issues, such as epilepsy or psychiatric disorders. Participants will undergo brain activity recordings during different phases of their headache condition. It's important to note that this study is currently recruiting participants, and both men and women aged between 18 and 75 are eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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