Coordinated Reset Deep Brain Stimulation for Essential Tremor
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Tremor Research Group Essential Tremor Rating Scale (TETRAS)
研究概览
简要总结
Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation. This study will evaluate the feasibility, safety and short-term efficacy of thalamic CR-DBS in upper extremity ET. The goal of this study is to evaluate the safety and short-term efficacy of thalamic CR- DBS in ET, including the acute (during CR-DBS) and carryover (following DBS cessation) effects, and compare these to those induced by clinically optimized T-DBS. To achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (UE) ET. The first aim is to identify the spatial location and peak frequency of tremor related oscillatory activities in VIM (Phase I). The second aim is to compare the acute effects of thalamic CR-DBS to clinically optimized T-DBS (Phase II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants will be blinded to the order of interventions they receive. The investigators assessing the severity of tremor and side effects through videos will also be blinded to the intervention condition.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of essential tremor (ET)
- •Age of 21 or over
- •Will be or has been implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
- •7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging of DBS targets at 7T MRI"
- •Planned post-operative CT scan
排除标准
- •History of musculoskeletal disorders that affect movement of the limbs or gait
- •Other significant neurological disorder
- •History of dementia or cognitive impairment that precludes them from getting DBS surgery
- •Significant psychiatric disease
- •On medication that could cause tremor
- •Prior brain surgery
- •Pregnant women
- •Evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation
- •Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
- •Other significant medical disorder that could impede study participation
研究组 & 干预措施
Coordinated Reset DBS Setting (CR-DBS)
Coordinated Reset DBS settings
干预措施: Deep brain stimulation (Device)
Clinically Optimized DBS Setting (T-DBS)
Traditional DBS settings
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
时间窗: 4 months
TETRAS is a rating scale introduced by the Tremor Research Group which has undergone extensive performance evaluations7. The TETRAS Activities of Daily Living Subscale (TETRAS-ADL) rates tremor's impact on activities of daily living, using 12 test items with each item scored from 0-4 (increasing with severity). The TETRAS-ADL total score range is 0-48. The TETRAS performance subscale (TETRAS-P) consists of 16 scored items designed to measure essential tremor of the head, face, voice, upper extremity, lower extremity and trunk, with each item scored from 0-4 (increasing with severity). Specific amplitude measurements are used to guide the ratings for each item. Tasks of spiral drawing, handwriting and object holding are included. The TETRAS-P total score range is 0-64. The total TETRAS score, including both TETRAS-ADL and TETRAS-P, ranges from 0 to 112.
次要结局
- Quantitative Archimedes Spirals(4 months)
- Quantitative Speech Analysis(2 months)
- Quality of Life in Essential Tremor (QUEST)(4 months)
- Dot Approximation Task(4 months)
- Bain Tremor Disability Scale (BTDS)(4 months)
- Quantitative Gait Analysis(2 months)
- Instrumented Tremor Measurement(4 months)
- Brief Ataxia Rating Scale (BARS)(2 months)