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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
- 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 Neuromotor Recovery Laboratory (NRL) and/or affiliated BU clinical research facilities.
Specific Aims
The study pursues three primary aims:
- To characterize the neural correlates of gait dysfunction in people with AD using simultaneous brain-body imaging during walking under typical and challenging conditions.
- To evaluate whether baseline neurocognitive profile (degree and domain of impairment) predicts individual responsiveness to RAS during walking.
- To quantify the acute effects of RAS on gait and functional brain connectivity in individuals with AD compared to neurotypical older adults.
- 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).
- 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.
- 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.
- 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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Regina Sloutsky, PT, DPT, PhD
- Número de telefone: 617-500-3645
- E-mail: reginas@bu.edu
Estude backup de contato
- Nome: Louis N Awad, PT, DPT, PhD
- Número de telefone: 617-500-3645
- E-mail: louawad@bu.edu
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02215
- Recrutamento
- Boston University Neuromotor Recovery Laboratory
-
Contato:
- Louis N Awad, PT, DPT, PhD
- Número de telefone: 617-500-3645
- E-mail: gaitlab@bu.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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).
|
Rhythmic Auditory stimulation
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional brain network connectivity
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Louis N Awad, PT, DPT, PhD, Boston University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 8203
- 5U24AG084436-02 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Metronome
-
Metronom HealthMedical University of GrazDesconhecidoDiabetes Mellitus, Tipo 2 | Diabetes Mellitus, Tipo 1 | Diabetes melitoÁustria, Dinamarca