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临床试验/NCT01100762
NCT01100762已完成不适用

Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Cadence

研究概览

简要总结

The use of low level electrical stimulation when applied over the head, also called transcranial direct current stimulation (tDCS), is being tested by several groups of researchers to see if tDCS can improve movements of persons with damage to the brain. The safety and potential benefits of tDCS to children or adults patients who are paralyzed because of brain damage are reported in the medical literature. In addition, some patients with Parkinson's disease (PD) experience improvement in memory and report better use of the hand after tDCS. The treatment requires putting electrodes (pads) over the head and sending very small amount of electrical current that the patient may feel as "little tingling". Application of tDCS takes 20 min. In this study we wish to test if tDCS application can improve stepping and walking ability of subjects with PD and if the improvement is the same as when walking on treadmill. We plan to test the subject's ability to step when pulled by a laboratory testing system and also test his/her walking ability. There will be 3 sessions 7 days apart. In the first session the subject will be tested then treated for 20 min with tDCS and then tested again. In the second session the subject will be tested then walk on a treadmill for 20 min then tested again. In the third session the subject will be tested then walk on the treadmill for 20 min while receiving also tDCS and tested one last time at the end of the session. Each session will take between 2 and 3 hours.

详细描述

Recent advances in non-invasive electrical stimulation technology including transcranial direct current stimulation (tDCS) have provided novel and low risk options to rehabilitate the impaired ability of the central nervous system (CNS) to process sensorimotor information. Furthermore, tDCS appears to enhance CNS connectivity and there is preliminary evidence indicating that patients with Parkinson's Disease (PD) may experience improvement in working memory, the Unified Parkinson's Disease Rating Scale, simple reaction time and the Purdue Pegboard test. tDCS is inexpensive, portable and available for repeated home use. It may provide long-lasting enhancement of cortical activity in part because tDCS is easy to administer frequently and to combine it with other rehabilitation approaches including posture and gait training. However to date, no study has examined quantitatively the effects of tDCS on posture control and walking ability in patients with PD. As a first step we plan to identify the immediate effects of tDCS, as well as the added value of tDCS to treadmill exercise training, to improve posture and gait of individuals with PD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diagnosis of adult onset of PD
  • A history of freezing of gait (FOG) as evidence by clinical assessment
  • A stable regimen of anti-parkinsonian medications
  • Ability to walk at least 10m without assistance
  • Ability to walk on a treadmill for 20 minutes
  • Personal weight of less than 500 Lb (because the suspension harness over the treadmill is limited to 500 Lb
  • Stage 3 of the Hoehn and Yahr disability scale
  • A score of >24 on the Mini Mental State Examination

排除标准

  • Evidence of any clinically significant functional impairment related to cardiovascular, pulmonary, metabolic, other neurologic or musculoskeletal disease criterial that would preclude participation in training
  • Any medical condition that might require other medical or surgical treatment during the study period
  • A history of brain surgery or placement of a deep brain stimulator
  • Dyskinesias > grade 2 on the Unified Parkinson's Disease Rating Scale (UPDRS)
  • Any uncorrected vision or hearing problems that may limit daily activities or communication

研究组 & 干预措施

Single Group

Experimental

10 subjects with Parkinson's Disease receiving tPCS during the first session, treadmill walk, 7-10 days later (second session, and combined tPCS and treadmill 7-10 days week later (third session)

干预措施: Cranial Electric Stimulation (CES) (Device)

Single Group

Experimental

10 subjects with Parkinson's Disease receiving tPCS during the first session, treadmill walk, 7-10 days later (second session, and combined tPCS and treadmill 7-10 days week later (third session)

干预措施: Treadmill (Device)

Single Group

Experimental

10 subjects with Parkinson's Disease receiving tPCS during the first session, treadmill walk, 7-10 days later (second session, and combined tPCS and treadmill 7-10 days week later (third session)

干预措施: CES and Treadmill (Device)

结局指标

主要结局

Cadence

时间窗: Data collection occurred before and immediately after each training session

Cadence was measured in steps per minute

Gait Velocity

时间窗: Data collection occurred before and immediately after each training session

Gait Velocity was measured in meters per second

Stride Length

时间窗: Data collection occurred before and immediately after each training session

Stride Length was measured in centimeters

First Step Velocity

时间窗: Data collection occurred before and immediately after each training session

First step velocity was measured in meters per second

Number of Steps to Regain Balance

时间窗: Data collection occurred before and immediately after each training session

Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.

First Step Length

时间窗: Data collection occurred before and immediately after each training session

First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gad Alon

Associate Professor

University of Maryland, Baltimore

研究点 (2)

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