Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Therapeutic window
研究概览
简要总结
This will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS.
详细描述
Specific Aims:
- To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor.
Hypothesis: directional DBS will result in a wider TW than nondirectional DBS. 2. To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control. 3. To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control. 4. To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration
排除标准
- •Patients who have decided not to receive DBS for control of their medication-refractory essential tremor.
- •Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia).
- •Prior history of deep brain stimulation.
- •Prior history of thalamotomy.
- •A history or signs of dystonia, ataxia or parkinsonism.
- •Task specific tremor.
- •Orthostatic tremor.
- •Patients with cardiac pacemakers, defibrillators, or neurostimulators.
- •Patients who require MRI, ECT, rTMS, or diathermy.
- •Subjects with other type of neurological disease or injury.
研究组 & 干预措施
Directional deep brain stimulation
Deep brain stimulation delivered in a directional manner within an axial plane
干预措施: Deep brain stimulation of the VIM Thalamic nuclei (Device)
Nondirectional deep brain stimulation
Deep brain stimulation delivered in a nondirectional manner within an axial plane
干预措施: Deep brain stimulation of the VIM Thalamic nuclei (Device)
结局指标
主要结局
Therapeutic window
时间窗: 3 months
Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps
次要结局
- Improvement of tremor(3 months)
- Compare the effects of directional versus nondirectional DBS on self perception of speech(3 months)
- Compare the effects of directional versus nondirectional DBS on balance and gait(3 months)
- Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech(3 months)
研究者
Matthew Brodsky
Associate Professor of Neurology
Oregon Health and Science University