Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective fMRI Study
December 19, 2023 updated by: Women's Hospital School Of Medicine Zhejiang University
Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective Functional Magnetic Resonance Imaging Study
Observational prospective study with an analysis of the changes in brain structure and related functional connectivity in women with dysmenorrhea.
Study Overview
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 Type
Observational
Enrollment (Estimated)
20
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
dysmenorrhea
|
Dysmenorrhea, defined as painful menstrual cramps of uterine origin, is the most common gynecological condition among women of reproductive age.
|
|
female healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The functional connectivity of functional magnetic resonance imaging
Time Frame: 1 month
|
Functional magnetic resonance imaging (fMRI)-based functional connectivity (FC) commonly characterizes the functional connections in the brain.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grey Matter volume
Time Frame: 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.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 4, 2023
First Submitted That Met QC Criteria
December 19, 2023
First Posted (Estimated)
December 21, 2023
Study Record Updates
Last Update Posted (Estimated)
December 21, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-20230284-R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.