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临床试验/DRKS00005316
DRKS00005316招募中未知

eurocognitive Specification of Dysfunctions within Basal Ganglia-Cortex Loops and their Therapeutic Modulation by Deep Brain Stimulation in Patients with Obsessive Compulsive Disorders and Tourette Syndrome - KFO219 TP7

niversitätsklinikum Köln0 个研究点目标入组 35 人开始时间: 2013年10月2日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
35

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • For OCD and Tourette patients:
  • - chronic course
  • - serious expression with subjective distress and significant impairment of psychosocial functioning levels
  • - The patient agrees after detailed education about DBS and gives his written informed consent
  • - The patient agrees to a detailed evaluation
  • For OCD patients:
  • - OCD (ICD-10: F42) is the main psychiatric diagnosis
  • - strong symptom severity as measured by the YBOCS score
  • - At least one documented fully implemented cognitive-behavioral psychotherapy without sufficient success
  • - at least two unsuccessful drug therapies with SSRIs or clomipramine for 10 weeks in adequate doses
  • - At least one unsuccessful drug augmentation carried out for 10 weeks with one of the following medications: lithium, buspirone or neuroleptics
  • For Tourette patients:
  • - Tourette Syndrome (ICD-10: F95.2) is the main psychiatric diagnosis
  • - strong symptom severity as measured by the score YGTSS
  • - Inadequate symptom relief through drug treatment strategies, as a minimum pre-treatment with preparations from all three pharmacological groups listed (neuroleptics, benzodiazepines, alpha-agonists). This should be documented with adequate doses of at least 3-month treatment periods.

排除标准

  • - Acute suicidality
  • - Simultaneously or previously existing schizophrenia according to DSM-IV criteria
  • - Abuse of or dependence on drugs or alcohol in the last six months
  • - Craniocerebral trauma in the anamnesis
  • - Clinically relevant internal or neurological diseases
  • - Pregnancy or breastfeeding
  • - Participation in a clinical trial within the last 30 days before the start of the study
  • - Intellectual deficit

研究者

发起方
niversitätsklinikum Köln

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