Investigating the Effects of Peripheral Electrical Stimulation in Combination With Low Intensity Focused Ultrasound for Upper Extremity Motor Symptoms in Patients With Parkinson Disease (PD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Averaged 1mV Motor Evoked Potential (MEP) Amplitude recorded from the right and left FDI, APB and ADM
研究概览
简要总结
Transcranial Ultrasound Stimulation (TUS) is an emerging non-invasive brain stimulation(NIBS) technique that can be used on both superficial and deep brain targets with a high spatial resolution as small as a few cubic millimeters. Functional Electrical stimulation is a peripheral stimulation technique researched and clinically used to restore motor function following conditions like stroke and Spinal cord injury. To date, there are no studies that have looked at the neuro modulatory effects of combining TUS and FES on motor symptoms in patients with Parkinson's disease. The current study aims to understand the neuromodulatory effects of combining tbFUS to bilateral primary motor cortex (M1) in Parkinsons's disease patients immediately followed by bilateral upper extremity FES of the hand muscles for improving motor symptoms.
详细描述
There are 3 study visits and for all of them patients will remain in ON dopaminergic medication condition. Each visit will be a minimum of 7 days apart.
Each visit will contain 1 of 3 combinations:
Combination #1: Real TUS +Sham FES; Combination #2: Sham TUS+ Real FES; Combination #3: Real TUS +Real FES
Definition of:
Real TUS: The Real TUS paradigm will consist of 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz). The Power of Real tbFUS will be set at 20W.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The subject will be blind to stimulation condition (sham/active TUS). The assessor for the finger accelerometry will be blind to stimulation condition (sham/active TUS). The UPDRS examination will be video-recorded and blindly assessed by a research team member.
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 (applicable for PD patients only)
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
- •Genetic mutations
- •Major systemic illness or infection
结局指标
主要结局
Averaged 1mV Motor Evoked Potential (MEP) Amplitude recorded from the right and left FDI, APB and ADM
时间窗: Baseline, immediately after sonication (T0) , T30 (immediately after FES) and T60 (30 minutes after FES).
To obtain this measurement from both hemispheres, a Transcranial magnetic stimulator's (TMS) power output (expressed as %Maximum Stimulator Output or %MSO) will be adjusted to an intensity that consistently evokes MEP peak-to-peak amplitudes of \~1mV in the right and left FDI when applied to the left primary motor cortex (LM1) and right motor cortex (RM1) respectively, before any neuromodulatory intervention (Pre-I 1mV).
次要结局
- Unified Parkinsons Disease Rating Scale (UPDRS)(Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).)
- Finger tapping task(Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).)
研究者
Robert Chen
Senior Scientist
University Health Network, Toronto