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

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

80

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Hunan
      • Changsha, Hunan, Cina, 410011
        • Reclutamento
        • Second Xiangya Hospital of Central South University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
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.
Healthy Participants
Age- and sex-matched healthy adults without hidradenitis suppurativa, other chronic skin diseases, chronic pain disorders, or major neurological or psychiatric disorders.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline
Lasso di tempo: 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.
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
Lasso di tempo: At baseline during a single resting-state fMRI visit
At baseline during a single resting-state fMRI visit
Between-Group Difference in Regional Homogeneity Derived From Resting-State fMRI at Baseline
Lasso di tempo: At baseline during a single resting-state fMRI visit
At baseline during a single resting-state fMRI visit
Between-Group Difference in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Baseline
Lasso di tempo: Correlations between the mean time series of selected seed regions and predefined brain regions will be calculated and transformed into standardized connectivity values.
Correlations between the mean time series of selected seed regions and predefined brain regions will be calculated and transformed into standardized connectivity values.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Change From Baseline in ALFF Derived From Resting-State fMRI at Month 3
Lasso di tempo: Baseline and 3 months after initiation of routine therapy
Baseline and 3 months after initiation of routine therapy
Change From Baseline in fALFF Derived From Resting-State fMRI at Month 3
Lasso di tempo: Baseline and 3 months after initiation of routine therapy
Baseline and 3 months after initiation of routine therapy
Change From Baseline in ReHo Derived From Resting-State fMRI at Month 3
Lasso di tempo: Baseline and 3 months after initiation of routine therapy
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
Lasso di tempo: Baseline and 3 months after initiation of routine therapy
Baseline and 3 months after initiation of routine therapy

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Yi Zhan, Second Xiangya Hospital of Central South University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 gennaio 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

4 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 agosto 2026

Primo Inserito (Effettivo)

10 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • LYF20250311

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .