DRKS00007959尚未招募未知
Functional imaging of regional blood flow changes within the tremor network due to Deep Brain Stimulation in the ventrolateral thalamus with H2O-PET - ColTrem II
Department of Neurology, University Hospital of Cologne0 个研究点目标入组 25 人开始时间: 2015年4月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 75 Years（—）
- 性别
- All
入选标准
- •ET-patients:
- •Male or female patients with the clinical diagnosis of essential tremor according to the Consensus statement of the Movement Disorder Society on Tremor; ET-Patients aged between 50-75 years; Disease duration of more than 5 years; Capacity for consent so that written informed consent can be achieved; ET-Patients with a formal indication to a treatment with Deep Brain Stimulation (DBS) due to a therapy-refractory manifestation on at least three different pharmaceutical options and with the indication to electrode placement in the ventrolateral thalamus (VLp/Vim); Tolerable tremor severity after switching off the stimulation (DBS-OFF)
- •Control subjects:
- •Subjects aged between 50-75 years; Capacity for consent so that written informed consent can be achieved
排除标准
- •ET-patients:
- •Persons without capacity for consent, minors as well as individuals who are accomodated in an institution due to official or legal regulations; ET-patients suffering from other conditions (e.g. Alzheimer's disease, dystonia, epilepsy) besides essential tremor; ET-pateints with presence of unambiguous unilateral symptoms or hypokinesia; Unilateral dopaminergic deficit in functional imaging (FP-CIT SPECT); ET-patients with a significant response of symptoms after oral administration of levodopa, Irregularities in previous MRI scans (such as e.g. cerebral ischaemia, cerebellar atrophy, head surgery, etc.); Excessive head tremor hampering lying on the back over 90 minutes; Presence of symptomatic tremor causes such as metabolic or psychogenic tremor or due to the intake of tremor facilitating substances/drugs respectively as a consequence of their withdrawal; Presence of life-threatening diseases; Severe psychiatric comorbidities; Pregnant or breastfeeding women; Visual or hearing impairment interfering in the testing; ET-patients taking part in other interventional studies;
- •Control subjects:
- •Persons without capacity for consent, minors as well as individuals who are accomodated in an institution due to official or legal regulations; Subjects suffering from severe neurological disorders; Subjects with a regular intake of drugs interfering with the central nervous system which cannot be discontinued from the evening of the day before the testing until after testing is completed; Presence of life-threatening diseases; Severe psychiatric comorbidities; Pregnant or breastfeeding women; visual or hearing impairment interfering in the testing; Control subjects taking part in other interventional studies;
研究者
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