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Role of Specific microRNAs in Cluster Headache

Role of Specific microRNAs in Cluster Headache: Implications for Disease Phenotype and Neuropeptide Expression

About This Trial

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).

Who May Be Eligible (Plain English)

\- Healthy Controls Who May Qualify: - age between \>18 and \<65 years Who Should NOT Join This Trial: - diagnosis of primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension type headache is allowed) - 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 - Episodic Cluster Headache Who May Qualify: - diagnosis of Episodic Cluster Headache according to ICHD-III criteria (at least 1 year at screening) - age between \>18 and \<65 years of both genders Who Should NOT Join This Trial: - concomitant diagnosis of other primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed) - diagnosis of other neurological disorders - diagnosis of medical conditions considered clinically relevant by the researcher - diagnosis of chronic pain syndrome of any nature - pregnant and lactating women - use of substances of abuse - Chronic Cluster Headache Who May Qualify: - diagnosis of Chronic Cluster Headache according to ICHD-III criteria (at least 1 year at screening) - age between \>18 and \<65 years of both genders Who Should NOT Join This Trial: - concomitant diagnosis of other primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed) - diagnosis of other neurological disorders - diagnosis of medical conditions considered clinically relevant by the researcher - diagnosis of chronic pain syndrome of any nature - pregnant and lactating women - use of substances of abuse Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

\- Healthy Controls Inclusion Criteria: * age between \>18 and \<65 years Exclusion Criteria: * diagnosis of primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension type headache is allowed) * 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 * Episodic Cluster Headache Inclusion Criteria: * diagnosis of Episodic Cluster Headache according to ICHD-III criteria (at least 1 year at screening) * age between \>18 and \<65 years of both genders Exclusion Criteria: * concomitant diagnosis of other primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed) * diagnosis of other neurological disorders * diagnosis of medical conditions considered clinically relevant by the researcher * diagnosis of chronic pain syndrome of any nature * pregnant and lactating women * use of substances of abuse * Chronic Cluster Headache Inclusion Criteria: * diagnosis of Chronic Cluster Headache according to ICHD-III criteria (at least 1 year at screening) * age between \>18 and \<65 years of both genders Exclusion Criteria: * concomitant diagnosis of other primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed) * diagnosis of other neurological disorders * diagnosis of medical conditions considered clinically relevant by the researcher * diagnosis of chronic pain syndrome of any nature * pregnant and lactating women * use of substances of abuse

Locations (1)

IRCCS Mondino Foundation

Pavia, Italy