Brain Structural and Functional Connectivity Changes in t... | NCT06178406

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

NCT06178406

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Status

Unknown status

Last Update Posted

Dec 21, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Dysmenorrhea

Interventions

dysmenorrhea

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 4, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Dec 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2023

Last Update Posted Date

Dec 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dysmenorrhea			Behavioral: dysmenorrhea
female healthy controls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dysmenorrhea	Behavioral	Dysmenorrhea, defined as painful menstrual cramps of uterine origin, is the most common gynecological condition among women of reproductive age.	dysmenorrhea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D004412	Dysmenorrhea

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain

Browse Leaves

Not provided

Browse Branches

Not provided