Exploration of Brain Functional Networks in Patients With Hidradenitis Suppurativa Using fMRI (NCT07755670) | Clinical Trial Compass
RecruitingNot Applicable
Exploration of Brain Functional Networks in Patients With Hidradenitis Suppurativa Using fMRI
China80 participantsStarted 2026-01-03
Plain-language summary
The goal of this observational study is to learn whether adults with hidradenitis suppurativa (HS) have changes in resting brain activity and how these changes are related to disease severity, pain, sleep, mood, and quality of life. The study will also examine whether brain activity changes after patients receive biologic or small-molecule treatment as part of their regular medical care.
The main questions it aims to answer are:
* Are resting brain activity patterns different between people with HS and healthy participants?
* Are these brain activity patterns related to HS severity, pain, sleep problems, anxiety, depression, and quality of life?
* Do brain activity patterns change after 3 months of routine treatment, and are these changes related to improvement in HS symptoms? Researchers will compare participants with HS with healthy participants of similar age and sex. A subgroup of participants with HS who receive biologic or small-molecule treatment as part of routine clinical care will also be assessed before and after treatment.
Participants may:
* Complete assessments of HS severity, pain, sleep, mood, and quality of life
* Undergo resting-state functional magnetic resonance imaging
* Undergo skin ultrasound and routine laboratory testing
* Allow photographs of affected skin areas to be taken
* Return for follow-up assessments for up to 3 months
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For Participants With Hidradenitis Suppurativa:
* Aged 18 to 45 years.
* Diagnosed with hidradenitis suppurativa according to established clinical diagnostic criteria.
* Able and willing to comply with the study procedures and follow-up assessments.
* Able to provide written informed consent and willing to permit photography of affected skin areas.
* No coexisting systemic lupus erythematosus, dermatomyositis, atopic dermatitis, steroid-dependent dermatitis, or other relevant skin diseases.
* No use of biologic or small-molecule therapy that may affect hidradenitis suppurativa symptoms within 3 months before enrollment.
* Right-handed according to the Edinburgh Handedness Inventory.
For Healthy Participants:
* Aged 18 to 55 years.
* No hidradenitis suppurativa or other chronic skin disease.
* No chronic pain disorder.
* No major neurological or psychiatric disorder.
* Right-handed according to the Edinburgh Handedness Inventory.
* Able to provide written informed consent and comply with the study procedures.
For the Longitudinal Treatment Cohort:
* Meets the eligibility criteria for participants with hidradenitis suppurativa.
* Is scheduled to receive biologic or small-molecule therapy for hidradenitis suppurativa as part of routine clinical care, as determined by the treating physician.
* Willing and able to complete assessments before treatment and during 3 months of follow-up.
Exclusion Criteria:
* Participation in another investigational drug s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline
Timeframe: At baseline during a single resting-state fMRI visit
2
Between-Group Difference in Fractional Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline
Timeframe: At baseline during a single resting-state fMRI visit
3
Between-Group Difference in Regional Homogeneity Derived From Resting-State fMRI at Baseline
Timeframe: At baseline during a single resting-state fMRI visit
4
Between-Group Difference in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Baseline
Timeframe: Correlations between the mean time series of selected seed regions and predefined brain regions will be calculated and transformed into standardized connectivity values.
Trial details
NCT IDNCT07755670
SponsorSecond Xiangya Hospital of Central South University