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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Regina Sloutsky, PT, DPT, PhD
- Número de teléfono: 617-500-3645
- Correo electrónico: reginas@bu.edu
Copia de seguridad de contactos de estudio
- Nombre: Louis N Awad, PT, DPT, PhD
- Número de teléfono: 617-500-3645
- Correo electrónico: louawad@bu.edu
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Reclutamiento
- Boston University Neuromotor Recovery Laboratory
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Contacto:
- Louis N Awad, PT, DPT, PhD
- Número de teléfono: 617-500-3645
- Correo electrónico: gaitlab@bu.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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).
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Rhythmic Auditory stimulation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional brain network connectivity
Periodo de tiempo: within session: baseline (no RAS) and RAS-assisted walking
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Functional connectivity between the Dorsal Attention Network and Default Mode Network measured using fNIRS during walking.
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within session: baseline (no RAS) and RAS-assisted walking
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Stride time variability
Periodo de tiempo: within session: baseline (no RAS) and RAS-assisted walking
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Variability in stride timing measured using inertial measurement units during walking.
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within session: baseline (no RAS) and RAS-assisted walking
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Gait speed
Periodo de tiempo: within session: baseline (no RAS) and RAS-assisted walking
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Average walking speed measured in meters per second during overground walking.
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within session: baseline (no RAS) and RAS-assisted walking
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Louis N Awad, PT, DPT, PhD, Boston University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8203
- 5U24AG084436-02 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
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