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临床试验/NCT03463590
NCT03463590Unknown不适用

Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
6
试验地点
1
主要终点
Change in Y-BOCSII Score

研究概览

简要总结

Deep brain stimulation (DBS) offers an effective and safe treatment for patients with debilitating, otherwise treatment-refractory obsessive-compulsive disorder(OCD). Although several target areas for DBS have been used for OCD, such as the ventral capsule/ventral striatum and the subthalamic nucleus, not all patients show a clinical response, varying from 10% to 61.5%. Exploring new DBS targets may be a key approach to improve this situation. The habenula is an evolutionarily conserved structure playing an important role in depression, punishment avoiding, reward, addiction, pain and circadian rhythms. The habenula can be considered a promising target for OCD treatment based on the following hypotheses and clinical observations.

  1. The lateral habenula DBS has significant clinical antidepressant effects.
  2. The habenula plays an important role in the regulation of dopamine and serotonin systems.
  3. Selective serotonin reuptake inhibitors, the first line treatment for OCD, are commonly used to treat clinical depression.
  4. The habenula serves as a 'negative reward center' that mediates or moderates stress, negative emotions and thoughts, aversive learning, and goal-directed behavior, which are core clinical symptoms and signs of OCD.
  5. In our hospital, DBS of the habenula produced a significant improvement in OCD symptoms in one patient who failed to respond to other treatments, including capsulotomy either alone or in combination combined with cingulumotomy.

These theoretical and clinical considerations indicate that the habenula can be seen as a promising DBS target for OCD treatment. This study is focused on the effectiveness of bilateral DBS of the habenula for patients with treatment-refractory OCD. Furthermore, the study is aimed at exploring the influence of DBS of the habenula on brain activity and cognition.

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 as having primary OCD according to DSM-IV criteria using the Structured Clinical Interview for DSM-IV Axis I disorders;
  • YBOCSII score ≥31;
  • Duration ≥2 years;
  • Refractoriness to therapy was defined as no response or insufficient response following at least 2 treatments with adequate trials or intolerance to two or three selective serotonin transporter inhibitors (SSRIs) and clomipramine, augmentation strategies (antipsychotics) and cognitive behavioral therapy.
  • Capacity to provide informed consent (understanding of the study purpose and methods.

排除标准

  • Except for those with major depressive disorder and mild anxiety disorders, patients with clinically significant comorbid DSM-IV diagnoses (such as schizophrenia, bipolar II disorder, alcohol or substance abuse in the last 6 months, current tic disorder, or body dysmorphic disorder)
  • Patients with severe personality disorders, assessed using the Structured Clinical Interview for DSM-IV Axis II disorders.
  • Serious and unstable organic diseases (e.g. unstable coronal heart disease);
  • Pregnancy and/or lactation.

结局指标

主要结局

Change in Y-BOCSII Score

时间窗: Baseline (preoperative),1 month, 3 months,6 months, 9 months

The score of the scale ranges from 0 to 50

Change in OCI-R Score

时间窗: Baseline (preoperative),1 month, 3 months,6 months, 9 months

The score of the scale ranges from 0 to 72

次要结局

  • changes in World Health Organization Quality of Life-BREF(WHO-BREF)(Baseline(preoperative),1 month, 3 months,6 months,9 months)
  • changes the MOS item short from health survey (SF-36)(Baseline(preoperative),1 month, 3 months,6 months,9 months)
  • changes in the Hamilton Anxiety Scale(HAMA-14)(Baseline(preoperative),1 month, 3 months, 6 months,9 months)
  • changes in FMRI signal(Baseline(preoperative),3 month, 6 months, 9 months)
  • Neuropsychological measures(Scores of cogstate battery)(Baseline(preoperative),1 month, 3months,6months,9months)
  • changes in the Hamilton Depression Scale(HAMD-17)(Baseline(preoperative),1 month, 3 months, 6 months,9 months)

研究者

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

Bomin Sun

Director of the Department of Functional Neurosurgery

Ruijin Hospital

研究点 (1)

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