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

NCT ID: NCT06178406

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dysmenorrhea

Keywords

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dysmenorrhea, magnetic resonance imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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dysmenorrhea

dysmenorrhea

Intervention Type BEHAVIORAL

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

female healthy controls

No interventions assigned to this group

Interventions

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dysmenorrhea

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IRB-20230284-R

Identifier Type: -

Identifier Source: org_study_id