이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

연구 개요

연구 유형

관찰

등록 (추정된)

80

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Hunan
      • Changsha, Hunan, 중국, 410011
        • 모병
        • Second Xiangya Hospital of Central South University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline
기간: 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
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
기간
Change From Baseline in ALFF Derived From Resting-State fMRI at Month 3
기간: 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
기간: 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
기간: 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
기간: Baseline and 3 months after initiation of routine therapy
Baseline and 3 months after initiation of routine therapy

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Yi Zhan, Second Xiangya Hospital of Central South University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 3일

기본 완료 (추정된)

2027년 1월 1일

연구 완료 (추정된)

2027년 1월 1일

연구 등록 날짜

최초 제출

2026년 8월 4일

QC 기준을 충족하는 최초 제출

2026년 8월 4일

처음 게시됨 (실제)

2026년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 4일

마지막으로 확인됨

2026년 8월 1일

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