Gender Differences and Features of the Clinical Course of Primary Headaches

NCT05760625 | Unknown

• 1 other identifier: 616.857-036:616.831:615.21
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The pathophysiological mechanisms that underlie primary headache disorders, such as migraine and cluster headache (CH), are complex and not yet fully clarified. While there is today little doubt that activation of the trigeminovascular system (TGVS) is responsible for the headache pain, the primary mechanisms, probably centrally mediated, leading to its activation and the generation of pain are still largely obscure. The trigeminal system is supposed to play a central role not only in migraine but also in cluster headache pathology. In vitro studies have demonstrated the expression of BDNF in trigeminal ganglion neurons. BDNF release is induced by trigeminal stimulation and nociceptive inputs. BDNF is a member of the neurotrophin family and has been recognized as an important modulator of nociceptive pathways. Interestingly, BDNF is co-expressed with CGRP in trigeminal ganglion neurons. CGRP is one of the key molecules in migraine and cluster headache pathogenesis. BDNF is an important marker of neuronal plasticity. It has also been associated with pain processing. Increased BDNF levels are observed in chronic pain syndromes. In order to understand the role of BDNF associated with other factors such as gender on headache attacks we aimed to determine whether migraine and cluster headache is correlated with brain derived neurotrophic factor (BDNF) level, gender and age.

Conditions

Primary Headache Disorder

Keywords

migraine; pain; attack; BDNF; neurotrophins

Outcome Measures

Primary Outcomes (1)

• Gender differences and features of the clinical course of primary headaches

  Increasing of BDNF during headache attacks in women were more than men

  2 years

Study Arms (3)

Migraine

In migraineurs, venous blood samples will be collected twice: outside and during migraine attacks prior to pain medication. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique.

Diagnostic Test: analysis BDNF

Tension type of headache

In patients with tension-type headache (outside attack) and healthy controls, one single blood sample will take. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique.

Diagnostic Test: analysis BDNF

Cluster headache

In cluster headache patients serum samples will be collected in and outside cluster bout. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique.

Diagnostic Test: analysis BDNF

Interventions

analysis BDNF DIAGNOSTIC_TEST

We analysed consentration of BDNF in venous blood of patient with primary headache

Cluster headache; Migraine; Tension type of headache

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients, males and females, were included if they consented to study participation, and were aged between 18 and 45 years

You may qualify if:

• Migraine patients were included if they suffered from at least one, but no more than eight migraine attacks per month, and had not taken any pain medication including non-steroidal anti inflammatory drugs (NSAIDs), triptans or opioids 48 h prior to blood sample collection and if phone contact was possible 3 days after blood sampling.

Sponsors & Collaborators

• Tashkent Medical Academy: lead

Study Sites (1)

Tashkent Medical Academy

Tashkent, Olmazor District, 100109, Uzbekistan

Location

MeSH Terms

Conditions

Headache Disorders, Primary; Migraine Disorders; Pain

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bahtigul Holmuratova, PhD student

  Tashkent Medical Academy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Bahtigul

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: December 10, 2020
• Primary Completion: October 20, 2022
• Study Completion: March 21, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)