Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06503328

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

Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2024-07-16

100

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cluster headache (CH) is a primary headache disorder with complex causes that are not fully understood. This research aims to study the role of specific microRNAs (miRNAs) and neuropeptides in people with different types of cluster headaches, including episodic CH in active and remission phases, chronic CH, and healthy controls. The study focuses on miRNAs involved in pain and inflammation and neuropeptides that may trigger CH attacks, to better understand the disease and its biological markers. Participants include healthy volunteers and patients with diagnosed episodic or chronic cluster headache. Each person will have one visit involving blood sampling after fasting, clinical and demographic data collection, and completing questionnaires about headache impact. Blood samples will be analyzed to measure gene expression levels of miR-382-5p, miR-34a-5p, and miR-155 in blood cells, and plasma levels of neuropeptides CGRP, PACAP, and VIP. The study groups are defined by their CH status and phase. During the single study visit, participants will be evaluated after an overnight fast and blood samples collected during a pain-free period. They will complete questionnaires including MIDAS, HIT-6, and CHIQ to assess headache impact and disability. Researchers will monitor participants for at least two hours following blood sampling to ensure no immediate CH attack occurs. The main outcome measured is the gene expression of miR-382-5p, with secondary outcomes including other miRNAs, neuropeptide levels, and questionnaire scores. The total study duration for each participant is one visit.

CONDITIONS

Brief 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...

  • Healthy controls aged over 18 and under 65 years
  • Diagnosis of Episodic Cluster Headache for at least 1 year, aged over 18 and under 65 years
  • Diagnosis of Chronic Cluster Headache for at least 1 year, aged over 18 and under 65 years
  • Both genders included
Not Eligible

You will not qualify if you...

  • Diagnosis of primary or secondary headache disorders other than sporadic tension headache
  • Diagnosis of neurological disorders
  • Diagnosis of medical conditions considered clinically relevant by the researcher
  • Pregnant or lactating women
  • Use of NSAIDs, triptans, or opiates in the previous 24 hours (for healthy controls)
  • Diagnosis of chronic pain syndrome (for episodic and chronic cluster headache groups)
  • Use of substances of abuse (for episodic and chronic cluster headache groups)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Diagnostic Evaluation

Duration - Single evaluation at study visit

Participants undergo clinical and demographic data collection, fasting venous blood sampling, and complete questionnaires to evaluate miRNA gene expression and neuropeptide plasma levels related to cluster headache.

1 visit (in-person) with fasting blood sampling and questionnaire completion

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

F

Francescantonio Cammarota, MD

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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Published Research Related To This Trial

Plasma levels of CGRP and expression of specific microRNAs in blood cells of episodic and chronic migraine subjects: towards the identification of a panel of peripheral biomarkers of migraine?

Rosaria Greco, Roberto De Icco, Chiara Demartini...

https://pubmed.ncbi.nlm.nih.gov/33066724

Effect of Infusion of Calcitonin Gene-Related Peptide on Cluster Headache Attacks: A Randomized Clinical Trial.

Anne Luise H Vollesen, Agneta Snoer, Rasmus P Beske...

https://pubmed.ncbi.nlm.nih.gov/29987329

The effect of pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide in cluster headache.

Anne Luise H Vollesen, Agneta Snoer, Basit Chaudhry...

https://pubmed.ncbi.nlm.nih.gov/32962406