DysmenorrheaNCT06178406
Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective fMRI Study
An observational study of Dysmenorrhea, run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
Observational prospective study with an analysis of the changes in brain structure and related functional connectivity in women with dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- dysmenorrhea
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysmenorrhea
- Being tested
- dysmenorrhea
- Keywords
- dysmenorrhea, magnetic resonance imaging
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dysmenorrheaBehavioural
Dysmenorrhea, defined as painful menstrual cramps of uterine origin, is the most common gynecological condition among women of reproductive age.
| Study group | Role | What they receive |
|---|---|---|
| dysmenorrhea | Not described Receives: Behavioral: dysmenorrhea | |
| female healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178406
- Sponsor's protocol ID
- IRB-20230284-R
- Status last verified
- Dec 2023
- First submitted
- 4 Sep 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Structural and Functional Connectivity Changes in the Period of Dysmenorrhea: a Prospective Functional Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT06178406
- Acronym / sponsor ID
- IRB-20230284-R
- Conditions
- Dysmenorrhea
- Keywords
- dysmenorrhea, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dysmenorrhea | – | Behavioral: dysmenorrhea |
| female healthy controls | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dysmenorrheaDysmenorrhea, defined as painful menstrual cramps of uterine origin, is the most common gynecological condition among women of reproductive age. | Behavioural | dysmenorrhea |
Primary outcome
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 secondary outcome
Grey Matter volume
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysmenorrhea, run by Women's Hospital School Of Medicine Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The functional connectivity of functional magnetic resonance imaging (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.