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临床试验/NCT05092243
NCT05092243Unknown不适用

Exploit the Functional Higher Neural Connectivity and Electrophysiological Intervention of Freezing of Gait in Parkinson's Disease and Supranuclear Palsy During Different Ambulatory Complexities

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Electroencephalogram recording before and after the tDCS session

研究概览

简要总结

In the current proposal, investigators will investigate three crucial issues of FOG. Firstly, investigators will identify the possible source(s) of FOG in PD and PSP patients during unconstrained walking using a 64-channel ambulatory recorder. The investigators will explore the electric neural sources of FOG and brain connectivity. Secondarily, fMRI during motor imagery will be performed to examine the brain regions involved in the FOG patients. The investigators will merge the electrophysiological and imaging findings to detect the possible neurovascular coupling or uncoupling. Thirdly, electric intervention with transcranial direct current stimulation (tDCS) will be conducted to see whether the FOG situation can be ameliorated in PD and PSP patients. The investigators will deliver a 5-day session of tDCS to the leg motor cortex of the FOG patients to examine whether the intervention will benefit the patients in a double blind randomized design. Six assessments with different combinations of clinical scaling, gait analysis, electrophysiological investigation and fMRI examinations before and after tDCS will be conducted. Besides, there is no long-term cohort investigation of tDCS on neurodegenerative patients with FOG. The investigators will have a 3-year follow-up with a 1-month interval open-label stimulation paradigm for the patients who remained voluntarily after the termination of the initial short-term trials.

详细描述

The main goal of the first part of the 3-year project is to identify the source(s) of FOG with electrophysiological recording. The investigators will conduct concomitant high density Electroencephalographic and leg electromyographic recording to investigate subjects with and without FOG under unrestrained walking in the gait laboratory. The acquisitive signals from 64 montages will be decomposed first by independent component analysis (ICA) for further source localization of FOG. The event (FOG) related synchronization and desynchronization of different frequency bands of EEG will also be investigated to understand the neurophysiological implications of brain wave oscillations for the generation of FOG. In addition, the cerebello-thalamo-cortical pathway function will be assessed with magnetic paired associative stimulation in patients to probe the role of cerebellum in the pathogenesis of FOG. In the second part of the project, fMRI study will be adopted by having the subjects perform video-guided motor imagery of simple and complex walking situations. Block design paradigms will be delivered for signal acquisition. The signals will be analyzed by ICA before further processing for activation analysis. The connectivity map will beoverlaid with that of electric recording to examine the neurovascular coupling or uncoupling. In the third part of the project, investigators will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the leg motor cortex of the FOG patients to examine whether the intervention will benefit the patients in a doubleblind randomized cross-over design.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients meet the diagnosis of PD or PSP based on the established consensus criteria

排除标准

  • •Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations
  • •Functional III or above congestive heart failure, or cancer with distant metastasis
  • •Hoehn and Yahr stage 5 in PD or PSP

研究组 & 干预措施

real tDCS

Experimental

In transcranial direct current stimulation, the anodal pad was tapped over the primary motor cortex and the cathode pad was adhered of the contralateral frontal region. A constant current of 2.0 mA will be apply for up to 20 mins.

干预措施: Transcranial direct current stimulation (Device)

sham tDCS

Sham Comparator

In transcranial direct current stimulation, the sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA.

干预措施: Transcranial direct current stimulation (Device)

结局指标

主要结局

Electroencephalogram recording before and after the tDCS session

时间窗: baseline / 2 days, 2 and 4 weeks after the end of the tDCS session

Gait recording by 64 channels EEG device. Four different frequency bands ( theta, alpha, beta, and gamma) will be investigated. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.

Electromyography recording before and after the tDCS session

时间窗: baseline / 2 days, 2 and 4 weeks after the end of the tDCS session

The 4 pairs of leg EMG recording during 50 meters walking. The EMG signals will be filtered with a band pass ranging from 0.05 to 70 Hz. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.

Functional magnetic resonance images examination before and after the tDCS session

时间窗: baseline / 2 days after the end of the tDCS session

fMRI scan will be performed on a 3.0T MR imager to detect the brain BOLD signal change in FOG. When fMRI was conducted, four different video tapes will be presented to the subjects:1.normal walking, 2.normal turning, 3.FOG during forward straight walking and 4.FOG during turning.

次要结局

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session(baseline / 2 days, 2 and 4 weeks after the end of the tDCS session)
  • Change in Progressive Supranuclear Palsy Rating Scale (PSPRS)(baseline / 2 days, 2 and 4 weeks after the end of the tDCS session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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