Exploration of Brain Functional Networks in Patients With Hidradenitis Suppurativa Using fMRI

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorSecond Xiangya Hospital of Central South University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Participation in another investigational drug study within 1 month before enrollment.

Alcohol or drug abuse or dependence within the previous 3 months.

Current use of medications that may lower the seizure threshold or current use of antidepressant medication.

Previous or current treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation.

Trial population

The study population will include adults with hidradenitis suppurativa evaluated at the Department of Dermatology of the Second Xiangya Hospital of Central South University and age- and sex-matched healthy participants without hidradenitis suppurativa or other chronic skin diseases. Participants with hidradenitis suppurativa will be recruited from the dermatology outpatient population. A subgroup of participants with hidradenitis suppurativa who receive biologic or small-molecule therapy as part of routine clinical care will participate in the 3-month longitudinal follow-up component.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine Biologic Therapy for Hidradenitis Suppurativa

    Biological/Vaccine

    Biologic therapy is prescribed by the treating physician as part of routine clinical care and is not assigned by the study protocol. The study observes changes in clinical outcomes and resting-state brain activity before treatment and during 3 months of follow-up.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: HS Cross-Sectional Cohort0 interventions
Group B: HS Longitudinal Treatment Cohort1 intervention
Group C: Healthy Participants0 interventions

Trial outcomes

Primary outcomes

1

Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline

Whole-brain amplitude of low-frequency fluctuation (ALFF) values will be derived from resting-state blood-oxygen-level-dependent functional magnetic resonance imaging. ALFF reflects the amplitude of spontaneous low-frequency fluctuations in the blood-oxygen-level-dependent signal. Voxel-wise ALFF values will be compared between participants with hidradenitis suppurativa and healthy participants.

Time frame
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

Time frame
At baseline during a single resting-state fMRI visit
3

Between-Group Difference in Regional Homogeneity Derived From Resting-State fMRI at Baseline

Time frame
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

Time frame
Correlations between the mean time series of selected seed regions and predefined brain regions will be calculated and transformed into standardized connectivity values.

Secondary outcomes

1

Change From Baseline in ALFF Derived From Resting-State fMRI at Month 3

Time frame
Baseline and 3 months after initiation of routine therapy
2

Change From Baseline in fALFF Derived From Resting-State fMRI at Month 3

Time frame
Baseline and 3 months after initiation of routine therapy
3

Change From Baseline in ReHo Derived From Resting-State fMRI at Month 3

Time frame
Baseline and 3 months after initiation of routine therapy
4

Change From Baseline in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Month 3

Time frame
Baseline and 3 months after initiation of routine therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.