Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06503328

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

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

IRCCS Mondino Foundation

Pavia, Italy, 27100

Actively Recruiting

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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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