Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Ataxia Differences between DBS and no DBS
研究概览
简要总结
The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.
详细描述
Objectives: In recent years, there has been a growing amount of evidence tying Essential Tremor (ET) to cerebellar dysfunction. This has been clinically observed, demonstrated through specific gait measures of ataxia (often involving tandem gait), and confirmed through Positron emission tomography (PET) imaging. Deep Brain stimulation for ET has become a widely utilized therapeutic intervention for patients, and the bilateral thalamic ventralis intermedius (VIM) is most commonly implanted. However, it has been noted that in some patients gait ataxia significantly worsens post-op. This initially was thought to be a result of disease progression, but recent studies have in fact shown that this is a DBS related phenomenon.
Methods: Participants will have two visits to either the Portland VA or Oregon Health & Science University (OHSU). At each visit, several assessments of balance, tremor, gait and balance, and DBS settings will be made. The gait and balance assessments will be performed by a unblinded and a blinded rater.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Essential Tremor diagnosis at least 3 years duration
- •Absence of other neurological signes (such as dystonia, ataxia, or Parkinsonism)
- •Patients must be able to walk 2 minutes unassisted.
- •Patients must be able to understand and consent to be in the study.
排除标准
- •Patients who have had changes in DBS settings within the last 3 months.
- •Patients who have had no initial improvement or response to DBS.
- •ET medication changes in the last month.
- •Actively abusing alcohol.
- •A neurologic diagnosis other than ET that in the investigator's opinion could affect gait and/or balance.
- •Atypical tremor disorder including by not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease, or parkinsonian syndrome.
结局指标
主要结局
Ataxia Differences between DBS and no DBS
时间窗: Visit 2 (after DBS has been turned off for 3-10 days)
Compare the Scale of the Assessment and Rating of Ataxia (SARA) total score between DBS and no DBS participants with essential tremor. This 8-item scale rates gait (0-8 points), stance (0-6 points), sitting (0-4 points), speech disturbance (0-6 points), finger chase (0-4 points), nose-finger test (0-4 points), fast alternating hand movements (0-4 points), and heel-shin slide (0-4 points). Motor activists of the four extremities (items 5-8) assessments are performed bilaterally, mean values to obtain a total score. Cumulative score ranges from 0 (no ataxia) to 40 (most severe ataxia).
次要结局
- Balance Confidence(Visit 2 (after DBS has been turned off for 3-10 days))
研究者
Amie Hiller, MD
Associate Professor
Oregon Health and Science University