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

NCT07659964 | Recruiting

• 2 other identifiers: 82035U24AG084436-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease (AD); Mild Cognitive Impairment (MCI)

Keywords

RAS

Outcome Measures

Primary Outcomes (3)

• Functional brain network connectivity

  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

  Variability in stride timing measured using inertial measurement units during walking.

  within session: baseline (no RAS) and RAS-assisted walking

• Gait speed

  Average walking speed measured in meters per second during overground walking.

  within session: baseline (no RAS) and RAS-assisted walking

Study Arms (1)

Effects of RAS on gait quality on brain activity in individuals with and without AD

EXPERIMENTAL

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).

Device: Metronome

Interventions

Metronome DEVICE

Rhythmic Auditory stimulation

Effects of RAS on gait quality on brain activity in individuals with and without AD

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Boston University Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• Lo OY, Halko MA, Devaney KJ, Wayne PM, Lipsitz LA, Manor B. Gait Variability Is Associated With the Strength of Functional Connectivity Between the Default and Dorsal Attention Brain Networks: Evidence From Multiple Cohorts. J Gerontol A Biol Sci Med Sci. 2021 Sep 13;76(10):e328-e334. doi: 10.1093/gerona/glab200.

  PMID: 34244725 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Louis N Awad, PT, DPT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Sloutsky, PT, DPT, PhD

CONTACT

617-500-3645; reginas@bu.edu

Louis N Awad, PT, DPT, PhD

CONTACT

617-500-3645; louawad@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)