Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective fMRI Study

Dysmenorrhea Clinical Trial

Official title:

Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective Functional Magnetic Resonance Imaging Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178406
• Other study ID #: IRB-20230284-R
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational prospective study with an analysis of the changes in brain structure and related functional connectivity in women with dysmenorrhea.

Description:

Dysmenorrhea is a common gynecological disease and chronic pain disorder.Understanding the neural mechanisms of dysmenorrhea and the brain changes affecting pain factors is important for finding dysmenorrhea treatment methods. The emergence and progress of non-invasive neuroimaging technology can help us better understand pain at the neural level. Recent developments in identifying brain-based biomarkers of pain through advances in advanced imaging can provide some foundations for predicting and detecting pain. Twenty patients with dysmenorrhea and twenty matched female healthy controls were recruited from our hospital. All participants underwent the head magnetic resonance imaging scans to calculate grey matter volume and Diffusion Tensor Imaging parameters. Questionnaire assessment was also conducted.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Right-handedness, as confirmed by the Edinburgh Handedness Inventory

• A regular menstrual cycle of approximately 21 to 35 days

• A history of menstrual pain longer than 6 months

• Not taking any medication or using other methods to treat dysmenorrhea in the past month

• Score of >= 40mm on the VAS (visual analogue scale) in recent three menstrual cycles

Exclusion Criteria:

• Any psychiatric or neurological disorders, particularly premenstrual dysphoric disorder

• Using oral contraceptives, hormonal supplements, or any central-acting medication (eg, opioid, antiepileptics) within 6 months before the study

• Having a metal or pacemaker implant, claustrophobia, or any contraindications to MR

• Head injury with loss of consciousness

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Behavioral:
• dysmenorrhea
Dysmenorrhea, defined as painful menstrual cramps of uterine origin, is the most common gynecological condition among women of reproductive age.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The functional connectivity of functional magnetic resonance imaging	Functional magnetic resonance imaging (fMRI)-based functional connectivity (FC) commonly characterizes the functional connections in the brain.	1 month
Secondary	Grey Matter volume	the grey matter volume is defined as the amount of grey matter that lies between the grey-white interface and the pia mater.	1 month