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

NCT06178406 | Unknown

• 1 other identifier: IRB-20230284-R
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dysmenorrhea

Keywords

dysmenorrhea, magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Grey Matter volume

  1 month

Study Arms (2)

dysmenorrhea

Behavioral: dysmenorrhea

female healthy controls

Interventions

dysmenorrhea BEHAVIORAL

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

dysmenorrhea

Eligibility Criteria

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

Study Population

All the patients with dysmenorrhea underwent pelvic ultrasonography to identify the cause of dysmenorrhea. The study will be conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Women's Hospital School of Medicine Zhejiang University. All participants will give their written informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: December 21, 2023
• Study Start: January 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12