Effects of Excitatory and Inhibitory LIFUS of GPi in Parkinsonian Patients Without DBS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Stop-Signal Task
研究概览
简要总结
Low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation (NIBS) technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. This study will look at the effects of two different LIFUS stimulations on task performance in patients with Parkinson's disease. The effects of real stimulation will also be compared to sham stimulation. The evaluations will include behavioral tasks on the computer, the Unified Parkinson's Disease Rating Scale (UPDRS) motor scoring, and finger accelerometry recordings. These will be done before the LIFUS simulations and repeated after. This is to evaluate the different mechanisms and efficacy of these stimulations on deep brain areas.
详细描述
The goal of this study is to evaluate the effects of two different deep brain LIFUS protocols on task performance in PD patients. We will use two different protocols (5 Hz theta Burst vs 10 Hz inhibitory), bilaterally on the GPi of PD patients in two different sessions and evaluate their performance in visuomotor tasks using stop signal paradigm. We will also use active sham in a separate session bilaterally on the occipital cortex, more specifically Brodmann area 19 to compare differences in tremor activity. We will record behavioral performance of the patients to disentangle effects of different TUS protocols on PD patients. We will also use finger accelerometer on the tremor dominant hand, to evaluate possible changes in tremor.
For each participant, there will be four visits. In the first visit, a structural MRI scan will be obtained. In the subsequent three visits, the LIFUS experiments including the behavioral tasks on the computer, UPDRS motor scoring, and finger accelerometry recordings will be conducted in random order. In these visits, the task performance (stop-signal task) will be recorded before and after applying the 3 different LIFUS paradigms: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm. Visits 2, 3, and 4 will be separated by at least 1 week each and theta burst TUS (2 minutes x2 =4 min), 10 Hz protocol (Burst length 30ms, period 1000, 30% dc. Total Time: 40 seconds x2= 80 seconds) and sham theta bust TUS will be tested in random order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-90 years of age
- •Confirmed diagnosis of Parkinson's disease
- •Stable dopaminergic medication dose for a minimum of 4 weeks
排除标准
- •History of stroke or seizure
- •Comorbid dementia
- •Scored below 22 on the Montreal Cognitive Assessment (MoCA)
- •Has intracranial implant(s) or device(s)
- •Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
- •Has a previous surgical intervention to treat the movement disorder such as lesioning or a Deep Brain Stimulation system in place.
- •Presence of metal implanted in body that is contraindicated in TMS/MRI/peripheral electrical stimulation
- •Pregnancy
- •Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study
- •Is on antipsychotics, anti-depressants, marijuana, or other recreational drugs that affect the nervous system
- •Major musculoskeletal or neuromuscular disease or disorder of the hands, wrists and limbs
- •Severe Dyskinesia
- •Major systemic illness or infection
研究组 & 干预措施
Low Intensity Focused Ultrasound
3 different LIFUS paradigms in random order: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm.
干预措施: LIFUS: Active 5 Hz Theta Burst (Device)
Low Intensity Focused Ultrasound
3 different LIFUS paradigms in random order: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm.
干预措施: LIFUS: Active 10 Hz (Device)
Low Intensity Focused Ultrasound
3 different LIFUS paradigms in random order: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of ~30mm.
干预措施: LIFUS: Sham (Device)
结局指标
主要结局
Stop-Signal Task
时间窗: Visits 2-4: before stimulation, 20 minutes post round 1 of stimulation, and 25 minutes post round 2 of stimulation
次要结局
- Unified Parkinsons Disease Rating Scale (UPDRS)(Visits 2-4: At the beginning of the visit, and at the end of the visit after all stimulation. Visits 2-4 will take place over at least 3 weeks as each visit is at least 1 week apart.)
- Rest Tremor(Visits 2-4: resting tremor will be recorded by an accelerometer periodically during each visit. This will be over at least 3 weeks, since each visit is at least 1 week apart.)
- Postural Tremor(Visit 2 - 4. At each visit, it will be recorded twice. Once before the stimulation and another after. This will take place over at least 3 weeks, since each visit is at least 1 week apart.)
研究者
Robert Chen
Senior Scientist
University Health Network, Toronto