A Trial of tPCS on Parkinson's Disease OFF State
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Changes in Network fragmentation using Quantitative Electroencephalography (EEG)
研究概览
简要总结
A significant number of patients with Parkinson's disease (PD) face motor fluctuations even after repeated titration of the dosing of Levodopa. Dealing with OFF state really becomes problematic for them. Aggravation of bradykinesia, rigidity, tremor and gait difficulty are the common problems in OFF state. Studies are going on drugs like Apomorphine as rescue therapy in OFF state. Recently there are studies with Noninvasive brain stimulation, as an evolving therapeutic option in different neurodegenerative diseases. In this study, the investigators are to evaluate the efficacy of transcranial pulsed current stimulation (tPCS) in the OFF state in PD patients. The investigators will give stimulation via tPCS (active/sham). EEG, Kinematic measurement of upper limb movement via KinArm, Unified Parkinson's Disease Rating Scale (UPDRS) scoring will be done and gait will be assessed via Gait Carpet - pre and post-stimulation. The investigators will evaluate the effectiveness of tPCS as a single modality or in combination with Levodopa in managing OFF state of PD.
详细描述
This will be a randomized sham-controlled trial. The investigators have planned to study the efficacy of Transcranial pulsed current stimulation (tPCS) in patients of Parkinson's disease (PD) in their OFF state. Each patient will come in 3 separate days in OFF state. They will first receive either active tPCS or sham tPCS or 3 tabs of Levodopa (100/25) in OFF state. Pre and post intervention analysis will be done. In those, who are receiving tPCS (active/sham), the investigators will give them Levodopa (100/25) after post stimulation assessment done. The patients will be assessed clinically by UPDRS III. EEG (for electrophysiological analysis), Gait Carpet (for Gait analysis) will also be done - before and after a single session of 20 min stimulation via tPCS. The investigators will also compare the effect of tPCS in OFF state, with that of Levodopa in OFF state.
The assessment will be done by-
- Unified Parkinson's disease rating scale III (UPDRS III)
- Gait via Gait Carpet
- Quantitative Electroencephalography (qEEG)
- KinARM
Transcranial pulsed current stimulation (tPCS) will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes. For this experiment, 20 minutes of stimulation will be performed. The stimulation would be done to the motor cortex (M1) or supplementary motor area (SMA), based on quantitative electroencephalography (qEEG) findings. For the sham stimulation, the electrode placement will be same, but the electric current will be ramped down 5 seconds.
Zeno Walkway is a pressure sensitive electronic roll-up walkway that measures the temporal and spatial parameters of gait which could in turn help in identifying any abnormalities in the gait. The patient walks on the Zeno Walkway mat before and after the tPCS stimulation to find the difference in the gait motion. The Zeno walkway will be used in conjunction with the ProtoKinetics Movement Analysis Software (PKMAS). These data will be captured and collated via the PKMAS software, resulting in numerous spatial, temporal and pressure-related gait parameters. Timed-up-and-go (TUG) (1-5minutes per trial) will be performed. The test consists of rising from chair, walking across the 20-foot gait carpet, turning around off the carpet, walking back and sitting down. This will be performed over 3 trials. Gait analysis provides various additional parameters as output such as stride length, line of progression, step length, toe-offs and other temporal and spatial parameters for analysis.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Idiopathic Parkinson's disease (IPD).
排除标准
- •Parkinson plus syndromes.
- •Drug-induced parkinsonism.
- •Patients who cannot walk independently or wheelchair-bound.
- •Patients who are not able to provide informed consent.
研究组 & 干预措施
Real tPCS
Patients will be randomized to any of the 3 arms. In Real tPCS arm, we will give active tPCS for 20 mins.
干预措施: Active tPCS (Device)
Sham tPCS
Patients will be randomized to any of the 3 arms. In Sham tPCS arm, we will give sham tPCS for 20 mins.
干预措施: Sham tPCS (Device)
Levodopa
Patients will be randomized to any of the 3 arms. In Levodopa arm, we will give 3 tablets of Levodopa-Carbidopa (100/25).
干预措施: Levodopa tablet (Drug)
结局指标
主要结局
Changes in Network fragmentation using Quantitative Electroencephalography (EEG)
时间窗: 3 months
Network fragmentation will be analyzed by 5 mins of resting quantitative Electroencephalography (EEG), pre and post stimulation. All frequency bands will be analyzed.
Change in upper limb motor kinetics
时间窗: 3 months
KinArm will be used pre and post stimulation to have objective measurement of upper limb motor function. Reaching task will be performed using standardized KinArm protocol. Visuomotor function of upper limb will be analyzed by postural control of arm with respect to x and y co-ordinates, angular velocity, acceleration, force and torque.
Change in Unified Parkinson's disease rating scale (UPDRS) part III
时间窗: 3 months
The effectiveness of tPCS in OFF state of PD will be evaluated. Unified Parkinson's disease rating scale (UPDRS) part III will be applied - pre and post stimulation. UPDRS Part III is motor examination that consists of speech, facial expression, rigidity, rest tremor, postural/action tremor, rapid alternating movements for testing bradykinesia, arising from chair, posture, gait, body bradykinesia, postural stability. In each subset, minimum score is 0 and maximum is 4. By adding, total UPDRS part III score is minimum 0 to maximum 108. Higher score means more severity of parkinsonism.
Changes in spatiotemporal gait measures using objective gait analysis
时间窗: 3 months
Zeno Walkway Gait carpet will be used and the spatiotemporal details of the gait will be analyzed by ProtoKinetics Movement Analysis Software (PKMAS) software, pre and post stimulation.
次要结局
未报告次要终点
研究者
Mandar Jog
Professor
Western University, Canada