Role of Specific microRNAs in Cluster Headache
ConditionCluster Headache
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age between >18 and <65 years
Disqualifiers
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
Trial population
We aim to enroll a representative population of patients affected by eCH in the active phase and in the remission phases and cCH. All patients will be consecutively enrolled among those attending the clinics of the Headache Science Center of the IRCCS Mondino Foundation of Pavia (Italy). A set of healthy controls, without a present or past diagnosis primary or secondary headaches, will be enrolled as control group.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 3 trial groupsGroup A: Healthy Controls
Group B: Episodic Cluster Headache
Group C: Chronic Cluster Headache
Trial outcomes
Primary outcomes
1
PBMCs gene expression of miR-382-5p
miR-382-5p gene expression in PBMCs will be evaluated by real-time reverse transcription (RT-PCR). This assessment will be then normalized with U6 (a type of small nuclear RNA used as housekeeping gene) and expressed as Relative Quantification (RQ).
Time frame
Single evaluation at study visit - baseline (T0)Secondary outcomes
1
PBMCs gene expression of miR-34a-5p and miR-155
miR-34a-5p and miRNA-155 gene expression will be evaluated by real-time reverse transcription (RT-PCR). This assessment will be then normalized with U6 (a type of small nuclear RNA used as housekeeping gene) and expressed as Relative Quantification (RQ).
Time frame
Single evaluation at study visit - baseline (T0)2
Plasma levels of CGRP alpha, PACAP and VIP
Plasma levels of CGRP alpha, CGRP beta, PACAP and VIP will be measured using validated commercial ELISA kits.
Time frame
Single evaluation at study visit - baseline (T0)3
Score of MIDAS, HIT-6, and CHIQ
MIDAS, HIT-6, CHIQ represent validated clinical scales to rate CH related disability.
Time frame
Single evaluation at study visit - baseline (T0)Sponsors and contacts
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Source ClinicalTrials.gov