跳至主要内容
临床试验/NCT02503930
NCT02503930Unknown不适用

The Effect of Transcranial Direct Cortical Stimulation (tDCS) on a Motor-cognitive Dual-task Performance of Parkinson's Patients

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 60 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Changes in frequency and severity of the freezing of gait phenomenon

研究概览

简要总结

The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Often, the performance of one or more of these simultaneously performed tasks may deteriorate when another task is carried out at the same time, even in healthy young adults. This reduction in performance is referred to as the DT deficit or DT cost and is typically much higher in patients with Parkinson's disease (PD) than in young adults or age-matched controls. In PD, this DT cost impairs the gait pattern, as manifested, for example, in increased gait variability, exacerbating instability and fall risk.

In the proposed study, would be evaluated the effects of tDCS on dual tasking performance following tDCS.

The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will increase DT performance and prefrontal activation.

详细描述

tDCS intervention: Noninvasive tDCS will be delivered by study personnel uninvolved with any other study procedures. In the study will be used a battery-driven electrical stimulator. Stimulation and sham condition will be performed based on previous studies. Briefly, the anode will be placed over the PFC and the cathode over the right supraorbital region. The real tDCS condition will consist of 20 min of continuous stimulation at target intensity of 1.5 mA. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions. For the sham condition, an inactive stimulation protocol would be followed, as compared with an 'off-target' active protocol, in order to minimize participant risk. After each session, subjects will complete a side effects questionnaire. The efficacy of tDCS blinding will also be assessed after the final session, by asking each subject to judge whether they received real or sham tDCS, as well as their certainty of this judgment. Pre- and post-tDCS assessments will include:

fMRI: All of the MR images will be acquired on a 3.0 T scanner using an 8-channel head coil. T1-weighted brain volume (BRAVO) acquisitions will evaluate gray matter (GM) volume and thickness, markers of brain atrophy. This sequence will measure the ratio of GM within the PFC to overall GM, which will then be used to quantify the level of activation within the PFC. T2* echo planner imaging acquisition will be used for all the DT paradigms including intrinsic functional connectivity. Intrinsic connectivity will be examined while subjects are not engaged in any particular task and are requested to lie still with their eyes open (i.e., resting state). To examine task related changes versus more generalized patterns of DT activations, the type of the cognitive task or the nature of the motor task will be different in each task. The researchers will specifically examine the contribution of a secondary task involving working memory (arithmetic processing vs. attention), conflict monitoring, and motor planning on DT related activations.

fNIRS : fNIRS will be used to investigate the role of the frontal lobe in DT walking and how it is affected by tDCS [Mirelman et al. 2014]. The fNIRS system (Oxymon MKIII; Artinis Medical Systems) consists of flexible circuit board that carries the near-infrared light sources and detectors. The fNIRS sources and detectors pairs will be placed over the left (Fp1) and right (Fp2) frontal cortex regions of the forehead, as previously reported.

Gait assessment: Gait parameters will include both spatial and temporal parameters obtained using body fixed wearable sensors (accelerometers and gyroscopes) [Weiss et al. 2015;Ben et al. 2015]. Parameters will include (but are not limited to) gait speed, stride length and stride time as well as rhythmicity measures such as stride to stride variability and gait regularity.

The UPDRS, fall history and fear of falling will also be assessed (e.g., Falls Efficacy Scale International, FES-I) to further characterize the cohort and explore possible confounds.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of idiopathic PD (defined by the UK Brain Bank criteria)
  • Hoehn and Yahr score between 1.5-3
  • Taking anti-parkinsonian medications.

排除标准

  • Mini Mental State Exam (MMSE) score =< 24
  • Brain surgery in the past including implanted DBS
  • Major depression (DSM-IV Criteria)
  • Cerebral Infarction with Residual Deficits Diagnosis
  • Neurological diseases (except from PD)
  • Orthopaedic or cardiovascular diseases that may affect walking and cognitive abilities.

结局指标

主要结局

Changes in frequency and severity of the freezing of gait phenomenon

时间窗: One week post intervention

The new version of the Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to baseline.

次要结局

  • Changes in cognitive performance(One week post intervention)
  • Immediate change in gait speed(One week post intervention)
  • Immediate change in gait variability(One week post intervention)
  • fMRI scans - changes in gray matter (GM) volume(One week post intervention)
  • fNIRS related frontal lobe activation - changes in tissue oxygenation(One week post intervention)

研究者

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

michal roll

Director of Research and Development

Tel-Aviv Sourasky Medical Center

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