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

Not yet recruiting

• Conditions: Dysmenorrhea
• Interventions: Behavioral: dysmenorrhea

• Registration Number: NCT06178406
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-09-04
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Study Start: 2024-01-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dysmenorrhea	dysmenorrhea	-

Primary Outcome Measures

Name	Time	Method
The functional connectivity of functional magnetic resonance imaging	1 month	Functional magnetic resonance imaging (fMRI)-based functional connectivity (FC) commonly characterizes the functional connections in the brain.

Secondary Outcome Measures

Name	Time	Method
Grey Matter volume	1 month	the grey matter volume is defined as the amount of grey matter that lies between the grey-white interface and the pia mater.