Exploration of Brain Functional Networks in Patients With Hidradenitis Suppurativa Using fMRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Between-Group Difference in Regional Homogeneity Derived From Resting-State fMRI at Baseline
Study Overview
Brief 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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.
- •Serious cardiac, hepatic, pulmonary, renal, thyroid, hematologic, or other systemic disease; malignant tumor; or another clinically significant abnormality that, in the investigator's judgment, makes participation inappropriate.
- •Pregnancy or breastfeeding.
- •Schizophrenia, bipolar disorder, or another major psychiatric disorder.
- •A neurological condition that may interfere with participation or interpretation of the imaging results, including markedly elevated intracranial pressure, intracranial vascular lesions, impaired consciousness, or inability to cooperate with study procedures.
- •Any contraindication to magnetic resonance imaging, including intracranial metallic foreign bodies, cardiac pacemakers, incompatible vascular or cardiac implants, or claustrophobia.
- •Inability to remain still or comply with resting-state functional magnetic resonance imaging procedures.
- •Unwillingness to allow study data to be collected.
Arms & Interventions
HS Cross-Sectional Cohort
Adults with hidradenitis suppurativa who participate in the cross-sectional comparison with healthy participants. They will undergo baseline clinical assessments, questionnaires, skin ultrasound, laboratory testing, and resting-state functional magnetic resonance imaging.
HS Longitudinal Treatment Cohort
A subgroup of adults with hidradenitis suppurativa who receive biologic or small-molecule therapy as part of routine clinical care. Participants will undergo assessments before treatment and during 3 months of follow-up, including repeat resting-state functional magnetic resonance imaging at month 3.
Intervention: Routine Biologic Therapy for Hidradenitis Suppurativa (Biological)
Healthy Participants
Age- and sex-matched healthy adults without hidradenitis suppurativa, other chronic skin diseases, chronic pain disorders, or major neurological or psychiatric disorders.
Outcomes
Primary Outcomes
Between-Group Difference in Regional Homogeneity Derived From Resting-State fMRI at Baseline
Time Frame: At baseline during a single resting-state fMRI visit
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.
Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline
Time Frame: At baseline during a single resting-state fMRI visit
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.
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
Secondary Outcomes
- Change From Baseline in fALFF Derived From Resting-State fMRI at Month 3(Baseline and 3 months after initiation of routine therapy)
- Change From Baseline in ReHo Derived From Resting-State fMRI at Month 3(Baseline and 3 months after initiation of routine therapy)
- Change From Baseline in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Month 3(Baseline and 3 months after initiation of routine therapy)
- Change From Baseline in ALFF Derived From Resting-State fMRI at Month 3(Baseline and 3 months after initiation of routine therapy)