NCT00634478撤回不适用
Pre-lemniscal Radiation Deep Brain Stimulation for ET
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Tremor rating scale axial score and total score
研究概览
简要总结
The hypothesis is that prelemniscal radiation (RaPRL) deep brain stimulation (DBS) is more effective for axial (head/neck/voice) tremor, and perhaps, appendicular tremor control in essential tremor patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of essential tremor based on clinical criteria established by the Essential Tremor Consortium
- •Moderate or severe axial-dominant (head/neck/voice) tremor (Tremor Rating Scale [TRS] face, tongue, voice, head or trunk tremor score of 2 or above)
- •May have bilateral appendicular tremor
- •Tremor refractory to at least two medications, including primidone and propranolol
- •Age between 21 and 75
- •Male or Female
- •Significant disability due to essential tremor despite medical treatment (TRS score of 2 or above in any one of the items 16-23 [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities])
排除标准
- •Tremor due to other etiologies
- •Presence of any other neurodegenerative disease
- •Presence of significant cognitive impairment
- •Presence of any medical condition that precludes neurological surgery
- •Patients with another implanted stimulator or metallic implant, e.g. cochlear implant, cardiac pacemaker, spinal cord stimulator, aneurysm clips
- •Patients who have a known need for future MRIs using a full body radio-frequency (RF) coil or a head transmit coil that extends over the chest area or that do not comply with Medtronic's "MRI Guidelines for Medtronic Deep Brain Simulation Systems"
- •Patients with a history of seizures
- •Patients with psychiatric illness that are not well controlled
- •Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 125,000 per cubic millimeter, PT and PTT not within normal limits)
- •Patients with brain tumors
研究组 & 干预措施
1
Experimental
preleminiscal radiation deep brain stimulation
干预措施: Pre-lemniscal Radiation Deep Brain Stimulation (Radiation)
2
Active Comparator
VIM deep brain stimulation
干预措施: Pre-lemniscal Radiation Deep Brain Stimulation (Radiation)
结局指标
主要结局
Tremor rating scale axial score and total score
时间窗: 3 months, 12 months and 24 months
次要结局
- quality of life (SF 36 and clinical global impression of change)(3 months, 12 months and 24 months)
研究者
研究点 (1)
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