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

NCT07755670 | Recruiting DMC

• 1 other identifier: LYF20250311
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (4)

• 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.

  At baseline during a single resting-state fMRI visit

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

  At baseline during a single resting-state fMRI visit

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

  At baseline during a single resting-state fMRI visit

• Between-Group Difference in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Baseline

  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 (4)

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

  Baseline and 3 months after initiation of routine therapy

• 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

Study Arms (3)

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

Routine Biologic Therapy for Hidradenitis Suppurativa BIOLOGICAL

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.

HS Longitudinal Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 36746171 BACKGROUND

• 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.

  PMID: 38069553 BACKGROUND

• 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.

  PMID: 32267024 BACKGROUND

• 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.

  PMID: 30874629 BACKGROUND

• 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.

  PMID: 24577438 BACKGROUND

• 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.

  PMID: 28884750 BACKGROUND

• 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.

  PMID: 32267476 BACKGROUND

• 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.

  PMID: 34406352 BACKGROUND

• 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.

  PMID: 31166590 BACKGROUND

• Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.

  PMID: 22236226 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Yi Zhan

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanyang Wu

CONTACT

+86-13676781917; wuyanyang@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: January 3, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)