- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07755670
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yanyang Wu
- Número de teléfono: +86-13676781917
- Correo electrónico: wuyanyang@csu.edu.cn
Ubicaciones de estudio
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Hunan
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Changsha, Hunan, Porcelana, 410011
- Reclutamiento
- Second Xiangya Hospital of Central South University
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Contacto:
- Yi Zhan
- Número de teléfono: +86-18673121224
- Correo electrónico: misseven69@csu.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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.
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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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Healthy Participants
Age- and sex-matched healthy adults without hidradenitis suppurativa, other chronic skin diseases, chronic pain disorders, or major neurological or psychiatric disorders.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline
Periodo de tiempo: At baseline during a single resting-state fMRI visit
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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.
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At baseline during a single resting-state fMRI visit
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Between-Group Difference in Fractional Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline
Periodo de tiempo: At baseline during a single resting-state fMRI visit
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At baseline during a single resting-state fMRI visit
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Between-Group Difference in Regional Homogeneity Derived From Resting-State fMRI at Baseline
Periodo de tiempo: At baseline during a single resting-state fMRI visit
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At baseline during a single resting-state fMRI visit
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Between-Group Difference in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Baseline
Periodo de tiempo: Correlations between the mean time series of selected seed regions and predefined brain regions will be calculated and transformed into standardized connectivity values.
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Correlations between the mean time series of selected seed regions and predefined brain regions will be calculated and transformed into standardized connectivity values.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Change From Baseline in ALFF Derived From Resting-State fMRI at Month 3
Periodo de tiempo: Baseline and 3 months after initiation of routine therapy
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Baseline and 3 months after initiation of routine therapy
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Change From Baseline in fALFF Derived From Resting-State fMRI at Month 3
Periodo de tiempo: Baseline and 3 months after initiation of routine therapy
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Baseline and 3 months after initiation of routine therapy
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Change From Baseline in ReHo Derived From Resting-State fMRI at Month 3
Periodo de tiempo: Baseline and 3 months after initiation of routine therapy
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Baseline and 3 months after initiation of routine therapy
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Change From Baseline in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Month 3
Periodo de tiempo: Baseline and 3 months after initiation of routine therapy
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Baseline and 3 months after initiation of routine therapy
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yi Zhan, Second Xiangya Hospital of Central South University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones
- Enfermedades de la piel
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Enfermedades de las glándulas sudoríparas
- Enfermedades De La Piel Bacterianas
- Enfermedades De La Piel Infecciosas
- Supuración
- Hidradenitis
- Enfermedades de la piel y del tejido conectivo
- Hidradenitis supurativa
Otros números de identificación del estudio
- LYF20250311
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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