跳至主要内容
临床试验/NCT06542224
NCT06542224招募中不适用

Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation

West China Hospital4 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年8月3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
16
试验地点
4
主要终点
Identifying an electrophysiological biomarker of OCD

研究概览

简要总结

Obsessive-compulsive disorder (OCD) is a complex and severe mental illness characterized by multiple symptoms and is considered a leading cause of non-fatal health loss. However, nearly 20% of patients do not respond to standard pharmacological or psychological treatments. Currently, we lack objective brain-based biomarkers. To address this issue, we used a novel device for electrophysiology recording and applied deep brain stimulation (DBS) to 16 OCD patients. In this study, we aim to use long-term invasive neural signal collection and machine learning techniques to reveal the complex relationship between these signals and OCD symptoms. By applying advanced machine learning algorithms, our goal is to establish highly accurate prediction models to identify biomarkers associated with the occurrence and progression of OCD. The research will focus on the spatiotemporal features of neural signals and build personalized OCD decoding models based on individual differences through the integration and analysis of large-scale data. By delving into the information contained in neural signals, we hope to provide academic and practical innovations for the development of personalized treatment approaches for OCD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with OCD according to the criteria in the DSM-
  • Age between 18 and 65 years.
  • Duration of illness of more than 3 years.
  • Ineffectiveness of systematic treatment with three types of serotonin reuptake inhibitors (including clomipramine) and augmentation agents, with no improvement after continuous high-dose serotonin reuptake inhibitor treatment for more than 12 weeks, or the occurrence of severe adverse drug reactions during treatment.
  • Ineffectiveness of CBT treatment or repeated refusal of CBT treatment.
  • Y-BOCS total score of 25 or higher.
  • Significant impairment in social functioning, such as inability to work or attend school, or a noticeable decline in personal life skills.
  • No severe impairment in insight, and capable of signing informed consent and surgery consent forms.

排除标准

  • Presence of bipolar disorder, schizoaffective disorder, schizophrenia, or other psychotic disorders.
  • Severe personality disorders.
  • Severe physical illnesses or organic brain diseases.
  • Diagnosis of alcohol or substance abuse and dependence according to DSM-IV criteria within one year prior to screening.
  • Study participants with contraindications for surgery, such as major medical comorbidities or inability to discontinue anticoagulant medications.
  • Preoperative head MRI showing significant structural abnormalities.
  • Contraindications for MRI examination (excluding the DBS implant or stimulator itself).
  • Pregnancy or breastfeeding.
  • Study participants currently enrolled in another research study unrelated to the current study.
  • Any condition that currently or in the future might endanger the safety of the study participant or prevent the successful participation in the study (including family support, medical, psychological, social, or geographical factors).

结局指标

主要结局

Identifying an electrophysiological biomarker of OCD

时间窗: 30 days

Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS

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

Botao Xiong

Assistant research fellow

West China Hospital

研究点 (4)

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