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RecruitingNCT07755670Updated Aug 10, 2026

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

An observational study in Hidradenitis Suppurativa (HS), sponsored by Second Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Second Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 45 Years
Sex
All
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Study 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
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Conditions studied

  • Hidradenitis Suppurativa (HS)
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In context

Hidradenitis Suppurativa

284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's planned enrollment of 80 is below the median of 170 across 72 observational studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Second Xiangya Hospital of Central South University is the lead sponsor of 87 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and willing to permit photography of affected skin areas.
  • No coexisting systemic lupus erythematosus, dermatomyositis, atopic dermatitis, -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

Exclusion Criteria:

  • Participation in another 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 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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Biological: Routine Biologic Therapy for Hidradenitis Suppurativa

  • Healthy Participants

    Age- and sex-matched healthy adults without hidradenitis suppurativa, other chronic skin diseases, chronic pain disorders, or major neurological or psychiatric disorders.

Interventions

  • BiologicalRoutine Biologic Therapy for Hidradenitis Suppurativa

    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.

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What researchers measure

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Kimball AB, Jemec GBE, Alavi A, Reguiai Z, Gottlieb AB, Bechara FG, Paul C, Giamarellos Bourboulis EJ, Villani AP, Schwinn A, Rueff F, Pillay Ramaya L, Reich A, Lobo I, Sinclair R, Passeron T, Martorell A, Mendes-Bastos P, Kokolakis G, Becherel PA, Wozniak MB, Martinez AL, Wei X, Uhlmann L, Passera A, Keefe D, Martin R, Field C, Chen L, Vandemeulebroecke M, Ravichandran S, Muscianisi E. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023 Mar 4;401(10378):747-761. doi: 10.1016/S0140-6736(23)00022-3. Epub 2023 Feb 3. PubMed 36746171 ↗
  • Wu H, Dai W, Hong Z, Qin Y, Yang M, Wang B, Liao J. Higher-order sensorimotor circuit of the whole-brain functional network involved in pruritus regulation in atopic dermatitis. J Eur Acad Dermatol Venereol. 2024 May;38(5):873-882. doi: 10.1111/jdv.19691. Epub 2023 Dec 8. PubMed 38069553 ↗
  • Najafi P, Ben Salem D, Carre JL, Misery L, Dufor O. Functional and anatomical brain connectivity in psoriasis patients and healthy controls: a pilot brain imaging study after exposure to mentally induced itch. J Eur Acad Dermatol Venereol. 2020 Nov;34(11):2557-2565. doi: 10.1111/jdv.16441. Epub 2020 May 19. PubMed 32267024 ↗
  • Baral P, Udit S, Chiu IM. Pain and immunity: implications for host defence. Nat Rev Immunol. 2019 Jul;19(7):433-447. doi: 10.1038/s41577-019-0147-2. PubMed 30874629 ↗
  • Grace PM, Hutchinson MR, Maier SF, Watkins LR. Pathological pain and the neuroimmune interface. Nat Rev Immunol. 2014 Apr;14(4):217-31. doi: 10.1038/nri3621. Epub 2014 Feb 28. PubMed 24577438 ↗
  • Davis KD, Flor H, Greely HT, Iannetti GD, Mackey S, Ploner M, Pustilnik A, Tracey I, Treede RD, Wager TD. Brain imaging tests for chronic pain: medical, legal and ethical issues and recommendations. Nat Rev Neurol. 2017 Oct;13(10):624-638. doi: 10.1038/nrneurol.2017.122. Epub 2017 Sep 8. PubMed 28884750 ↗
  • van Straalen KR. Chronic Pain in Hidradenitis Suppurativa Explained Through the Process of Central Sensitization. JAMA Dermatol. 2020 Jun 1;156(6):615-616. doi: 10.1001/jamadermatol.2020.0225. No abstract available. PubMed 32267476 ↗
  • Aarts P, Aitken JJ, van Straalen KR. Prevalence of Central Sensitization in Patients With Hidradenitis Suppurativa. JAMA Dermatol. 2021 Oct 1;157(10):1209-1212. doi: 10.1001/jamadermatol.2021.2918. PubMed 34406352 ↗
  • Machado MO, Stergiopoulos V, Maes M, Kurdyak PA, Lin PY, Wang LJ, Shyu YC, Firth J, Koyanagi A, Solmi M, Alavi A, Piguet V, Carvalho AF. Depression and Anxiety in Adults With Hidradenitis Suppurativa: A Systematic Review and Meta-analysis. JAMA Dermatol. 2019 Aug 1;155(8):939-945. doi: 10.1001/jamadermatol.2019.0759. PubMed 31166590 ↗
  • Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available. PubMed 22236226 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07755670
Lead sponsor
Second Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Jan 3, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Yanyang Wu
Contact
wuyanyang@csu.edu.cn
+86-13676781917
Yi Zhan
principal investigator · Second Xiangya Hospital of Central South University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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