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Use of a Mobile Brain-Body Imaging Approach to Evaluate the Effects of Rhythmic Auditory Stimulation on Gait and Brain Function in Alzheimer's Disease

2026年8月12日 更新者：Boston University Charles River Campus
Alzheimer's Disease (AD) is associated with impairments in both gait and cognition, significantly increasing fall risk. Falls are a leading cause of injury-related disability in older adults, and individuals with AD experience a nearly threefold higher rate of falls compared to neurotypical older adults. There is an urgent need for fall prevention interventions tailored to the unique deficits of individuals with AD. Converging evidence suggests that interventions aiming to reduce fall risk in AD should target both gait and cognition. Rhythmic music interventions, such as Rhythmic Auditory Stimulation (RAS) can harness global brain activation and auditory-motor entrainment to facilitate high-intensity exercise to alleviate AD-related neurocognitive and gait dysfunction. This study aims to assess the neural correlates of gait dysfunction in people with AD, evaluate if baseline neurocognitive impairment is predictive of the effects of RAS, and evaluate RAS benefits for individuals with AD.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

  1. Background and Scientific Rationale: Alzheimer's Disease (AD) is a progressive neurodegenerative disorder characterized by the accumulation of amyloid-beta plaques and tau neurofibrillary tangles, leading to widespread cortical and subcortical atrophy. While memory impairment is the most recognized clinical feature, AD also profoundly disrupts motor systems - particularly gait - through degeneration of frontal-subcortical circuits that govern attentional control of movement. Gait deficits in AD include reduced speed, shortened stride length, increased stride variability, and disproportionate cognitive-motor interference during dual-task conditions. These impairments reflect underlying disruptions in prefrontal-motor connectivity and are strongly predictive of fall events.

    Rhythmic Auditory Stimulation (RAS) is an interventional technique that harnesses the coupling between the auditory and motor systems. Rhythmic auditory cues delivered as an isochronous beat (with or without music) activate auditory-motor entrainment pathways, recruiting motor planning circuits in the basal ganglia, supplementary motor area, and cerebellum to promote more stable and efficient gait. RAS has demonstrated efficacy in improving gait parameters in neurological populations including Parkinson's disease and stroke. Its application in AD is motivated by evidence that music-based rhythmic stimuli elicit broad, cross-regional brain activation, including areas relatively spared in early AD, and may therefore provide a viable sensory scaffold for augmenting motor control even as cognitive reserve declines.

  2. Study Design and Overview: This is a single-session, non-randomized clinical trial enrolling 40 subjects -- 20 adults with a clinical diagnosis of AD (restricted to mild cognitive impairment, MCI) and 20 neurotypical older adults serving as a healthy comparison group. All participants complete one study visit conducted at the Boston University (BU) Neuromotor Recovery Laboratory (NRL) and/or affiliated BU clinical research facilities.

  3. Specific Aims

    The study pursues three primary aims:

    1. To characterize the neural correlates of gait dysfunction in people with AD using simultaneous brain-body imaging during walking under typical and challenging conditions.
    2. To evaluate whether baseline neurocognitive profile (degree and domain of impairment) predicts individual responsiveness to RAS during walking.
    3. To quantify the acute effects of RAS on gait and functional brain connectivity in individuals with AD compared to neurotypical older adults.
  4. Measurement Framework & Outcome Measures: Mobile Brain-Body Imaging (MoBI): A defining feature of this study is the use of a Mobile Brain-Body Imaging (MoBI) framework consisting of the concurrent capture of neural and biomechanical data during real-time ambulation. Brain activity is measured using functional near-infrared spectroscopy (fNIRS), a non-invasive optical neuroimaging technique that quantifies changes in cortical hemodynamics (oxy- and deoxy-hemoglobin concentration) as a proxy for regional neural activation. Unlike traditional neuroimaging modalities, fNIRS is tolerant of movement artifact, making it well-suited for ambulatory paradigms. Biomechanical gait data are collected concurrently using inertial measurement units (IMUs).
  5. Walking Conditions: Participants will walk overground under multiple conditions designed to vary cognitive and sensorimotor demand: a) walking with and without RAS and b) walking on an altered, gait-destablizing surface (foam mat or rocker-bottom footwear) to increase sensorimotor challenge. These conditions are intended to elicit a gradient of gait and neural responses and to probe the extent to which RAS can attenuate dual-task interference and cognitive-motor coupling deficits characteristic of AD.
  6. Cognitive Assessment: A standardized neuropsychological battery will be administered to all participants with AD to characterize baseline cognitive status and confirm MCI diagnosis. This battery includes the Montreal Cognitive Assessment (MoCA), Mini Mental Status Examination (MMSE), Consortium to Establish a Registry in Alzheimer's Disease (CERAD) delayed recall, Boston Naming Test (short form), Trail Making Test A and B, and verbal fluency measures. These assessments will be used to examine relationships between neurocognitive impairment profile and the magnitude of RAS benefit observed during walking.
  7. Significance: This study will generate foundational data linking neural mechanisms of gait dysfunction in AD with behavioral responsiveness to an accessible, non-pharmacological auditory-motor intervention in a population at high fall risk and with limited therapeutic options. Findings are intended to inform participant selection criteria and outcome measure development for future RAS-based clinical trials targeting fall prevention in AD.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Regina Sloutsky, PT, DPT, PhD
  • 电话号码：617-500-3645
  • 邮箱：reginas@bu.edu

研究联系人备份

  • 姓名：Louis N Awad, PT, DPT, PhD
  • 电话号码：617-500-3645
  • 邮箱：louawad@bu.edu

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Boston University Neuromotor Recovery Laboratory
        • 接触：
          • Louis N Awad, PT, DPT, PhD
          • 电话号码：617-500-3645
          • 邮箱：gaitlab@bu.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

General Inclusion (both healthy and AD populations):

  • Community-dwelling
  • Capable of walking short community distances (approximately 10-15 minutes at a time) without assistance from another person or a device (such as a cane).
  • Able to communicate with researchers
  • Age 50-90 (inclusive)

Population-specific Inclusion criteria:

  • Healthy -

    • No diagnosis of AD
  • AD population-

CERAD score of <1.5 SD from age + education adjusted norms on delayed recall domain or one or more other cognitive domains (i.e. language, attention).

MoCA score between 20-30 MMSE score between 25-30

Exclusion Criteria:

  • Presence of significant hearing impairment
  • Current orthopedic, neurologic or other medical condition that limits the ability to walk.

The MOCA, MMSE and CERAD tests will be completed in-person after the participant consents into the study. If the participant is determined to be ineligible based on their performance on these tests (compared to inclusion requirements listed above), they will be informed that they are not eligible for this study and the study visit will be cancelled. They will then be withdrawn from the study; their clinical tests and study documentation will be maintained for the purposes of completeness, but will not be used for any study analyses.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Effects of RAS on gait quality on brain activity in individuals with and without AD
Participants will complete overground walking assessments with and without rhythmic auditory stimulation (RAS) under varying sensorimotor conditions while gait and cortical activity are measured using wearable sensors (IMUs) and portable neuroimaging (fNIRS).
其他：Metronome
Rhythmic Auditory stimulation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Functional brain network connectivity
大体时间：within session: baseline (no RAS) and RAS-assisted walking
Functional connectivity between the Dorsal Attention Network and Default Mode Network measured using fNIRS during walking.
within session: baseline (no RAS) and RAS-assisted walking
Stride time variability
大体时间：within session: baseline (no RAS) and RAS-assisted walking
Variability in stride timing measured using inertial measurement units during walking.
within session: baseline (no RAS) and RAS-assisted walking
Gait speed
大体时间：within session: baseline (no RAS) and RAS-assisted walking
Average walking speed measured in meters per second during overground walking.
within session: baseline (no RAS) and RAS-assisted walking

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boston University Charles River Campus

合作者

National Institute on Aging (NIA)

调查人员

  • 首席研究员：Louis N Awad, PT, DPT, PhD、Boston University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 8203
  • 5U24AG084436-02 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in publications arising from this study will be made available. Shared data may include participant demographics, clinical characteristics, gait and biomechanical measures, neurophysiological measures, metronome settings for delivery of RAS, and other study variables necessary to reproduce published findings. Data will be de-identified prior to sharing in accordance with applicable regulations and institutional policies.

IPD 共享时间框架

Data will become available following publication of the primary study results or within 12 months of study completion, whichever occurs first, and will remain available for at least 5 years thereafter.

IPD 共享访问标准

De-identified data and supporting documentation will be made available to qualified researchers for scientifically sound research purposes. Requests will be reviewed by the study investigators and may require a data use agreement. Access will be provided in accordance with participant consent, institutional policies, and applicable regulations.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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