Recruiting

Rhythmic Auditory Stimulation

Sponsor:

Boston University Charles River Campus

Code:

NCT07659964

Conditions

Alzheimer Disease (AD)

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Metronome

Study Details

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)

Study ID

NCT07659964

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Metronome

Rhythmic Auditory stimulation

Primary outcome measure

  • Functional brain network connectivity [ Time Frame: within session: baseline (no RAS) and RAS-assisted walking ]
  • Stride time variability [ Time Frame: within session: baseline (no RAS) and RAS-assisted walking ]
  • Gait speed [ Time Frame: within session: baseline (no RAS) and RAS-assisted walking ]

Central Contacts and Locations

Central contacts

Regina Sloutsky, PT, DPT, PhD

617-500-3645reginas@bu.edu

Louis N Awad, PT, DPT, PhD

617-500-3645louawad@bu.edu

Locations

Boston University Neuromotor Recovery Laboratory

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Louis N Awad, PT, DPT, PhD

617-500-3645gaitlab@bu.edu

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • RAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-08-13.