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临床试验/NCT06294951
NCT06294951招募中不适用

Functional Magnetic Resonance Imaging Findings and Symptoms in Bladder Pain Syndrome: A Descriptive Study

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
fMRI findings

研究概览

简要总结

The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:

  1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population.
  2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.

Participants will undergo fMRI as well as other routine laboratory tests and queries.

详细描述

  1. Subject management

  2. Recruitment Subjects are recruited from the first consultation of patients; the specific place is the urology outpatient clinic of Renji Hospital, Shanghai Jiao Tong University School of Medicine; the specific time is from the beginning of recruiting subjects until the target of recruiting subjects is reached. If the attending physician initially judged that the criteria were met, recruitment is carried out after communication with the patient and family.

  3. Informed consent After the attending physician (investigator) finds patients who initially meet the enrolment criteria, he/she should give a written and verbal explanation to the subjects on the background, nature, significance, steps, benefits, risks, compensation, injury compensation, withdrawal, etc. of the study, and must obtain an informed consent form signed by each subject (or subject's legal representative). The informed consent form is dated, and the informed consent form and its copy are kept by the investigator and the subject respectively.

The informed consent form and its copy are kept by the investigator and the subject respectively. 3. Checking the entry criteria As soon as possible after the preliminary identification of subjects, the attending physician and the investigator will jointly check the enrolment criteria, make a formal decision on recruitment or non-recruitment into the group, and notify the subjects; the reasons for non-recruitment into the group should be explained in detail and recorded. 4. Examination of medical history and records of combined medications During the initial screening and verification of the enrollment criteria, the attending physician obtains the subject's past history, current medical history, personal history, as well as comorbid medications and previous medications. If necessary, while signing the informed consent form, the patient himself/herself or under the guidance of the attending physician will declare the medical history and combined medication records. 5. Assignment of screening numbers At the time of signing the informed consent, each patient is assigned a screening number, the rules for the preparation of the screening number are specified separately, and should ensure the principles of continuity, traceability, and de-specialization. 6. Visiting One visit is conducted on the day of signing the informed consent and one visit is conducted on the day of completion of screening, and the requirements and contents of the visit are described below.

Information to be collected on the day of signing informed consent (screening period) includes: demographic data, medical history, concomitant medications and therapies, adverse events and drug abuse; examinations and assessments to be completed include: VAS, IC-Q, PUF scale, Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAS), and Hamilton Anxiety Scale (HAS). (HAMD), and Hamilton Anxiety Scale (HAMA). The information collected during the screening period and the assessment results will be used as the basis for enrolment. After the decision of enrolment is made, the patients will enter the assessment period, during which the information to be collected includes: demographic data, medical history, adverse events; the tests and assessments to be completed include: urine routine, urine culture, urinary ultrasound, urodynamics, fMRI, VAS, IC-Q, PUF Scale, and Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA). Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA).

2.Data Management

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

fMRI findings

时间窗: 1 day (fMRI is performed once upon the recruitment of the study subject.)

The fMRI is acquired using a Siemens 3.0T MRI scanner. BOLD functional images are scanned using an echo planar imaging (EPI) sequence. The scanning parameters are: TR=2s, matrix size of 64\*64, number of layers=30, layer thickness=3.75\*3.75\*4.5mm, and bottom-up interval scanning. A total of 540 whole brain functional images are acquired. The relevant data acquired from fMRI should undergo the following pre-processing before generating findings: (1) data format conversion; (2) temporal layer correction; (3) head movement correction; (4) normalization; (5) smoothing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhebin Du

Attending Physician

RenJi Hospital

研究点 (1)

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