Actively Recruiting
Role of Specific microRNAs in Cluster Headache
Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2024-07-16
100
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cluster headache (CH) is a primary headache included in the trigeminal autonomic cephalalgias (TACs) according to the International Calssification of Headache Disorder, Third Edition. CH is characterized by a multifaceted and incompletely understood pathophysiology. Recent experimental evidence has increasingly emphasized the role of specific microRNAs (miRNAs) in the pathophysiology of primary headaches, including migraine. In a recent study, we observed an upregulation in the gene expression of two miRNAs, miR-382-5p and miR-34a-5p, in peripheral blood mononuclear cells (PBMCs) of subjects with chronic migraine (CM). These miRNAs are involved in inflammation modulation and the release of γ-aminobutyric acid (GABA). Notably, this upregulation correlated with the migraine phenotype and its severity. Several neuropeptides have been established to play an active role in CH. Studies by the Danish group have demonstrated that intravenous administration of CGRP, PACAP, or VIP can induce CH attacks in at least 50% of participants in the active phase of the disease. However, no data currently exists regarding the potential involvement of miRNAs in CH. Given this context, the primary aim of this study is to investigate the gene expression of specific miRNAs (miR-382-5p, miR-34a-5p, and miR-155) in PBMCs and plasma levels of neuropeptides (CGRP, PACAP, VIP) in subjects with episodic CH in the active phase (eCH-act), episodic CH in the remission phase (eCH-rem), chronic CH (cCH), and healthy control subjects (HCs).
CONDITIONS
Official Title
Role of Specific microRNAs in Cluster Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between >18 and <65 years
- Diagnosis of Episodic Cluster Headache according to ICHD-III criteria for at least 1 year
- Diagnosis of Chronic Cluster Headache according to ICHD-III criteria for at least 1 year
- Diagnosis of Episodic Cluster Headache in active or remission phase
- Healthy controls aged between >18 and <65 years
You will not qualify if you...
- Diagnosis of primary and/or secondary headache other than sporadic tension type headache
- Diagnosis of neurological disorders
- Diagnosis of medical conditions considered clinically relevant by the researcher
- Pregnant and lactating women
- Taking NSAIDs, triptans, or opiates in the previous 24 hours
- Diagnosis of chronic pain syndrome
- Use of substances of abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Mondino Foundation
Pavia, Italy, 27100
Actively Recruiting
Research Team
R
Roberto De Icco, MD, PhD
CONTACT
F
Francescantonio Cammarota, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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