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
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