Investigating brain connectivity in cluster headache patients
The Role of Resting State Networks Connectivity in Cluster Headache: a HD-EEG Study
IRCCS National Neurological Institute "C. Mondino" Foundation · NCT06206772
This study looks at how brain activity is connected in people with cluster headaches during painful episodes and when they are feeling better to see if it can help find new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation (other) |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06206772 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore brain connectivity in patients with episodic and chronic cluster headaches using high-density electroencephalogram (HD-EEG) recordings. The researchers will compare functional connectivity during active headache phases to remission phases, focusing on brain oscillations across various frequency bands. By analyzing these patterns, the study seeks to identify potential markers or predictors for therapeutic interventions in cluster headache management.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with episodic or chronic cluster headaches who have a history of the condition for at least one year.
Not a fit: Patients with a history of epilepsy, psychiatric illnesses, or other chronic pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from cluster headaches.
How similar studies have performed: While previous studies have explored EEG in migraine patients, this approach in cluster headache is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia
- Headache Science & Neurorehabilitation Center — Pavia, Italy (RECRUITING)
Study contacts
- Principal investigator: Roberto De Icco, MD — Headache Science ahd Neurorehabilitation Research Center
- Study coordinator: Cinzia Fattore, MD
- Email: cinzia.fattore@mondino.it
- Phone: 0382380385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cluster Headache, Headache Disorders